<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03832387</url>
  </required_header>
  <id_info>
    <org_study_id>HGCS03</org_study_id>
    <nct_id>NCT03832387</nct_id>
  </id_info>
  <brief_title>Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure</brief_title>
  <official_title>Non-Invasive Mechanical Ventilation Versus Oxygen Therapy in Patients With Acute Respiratory Failure After Extubation in a Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after&#xD;
      extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus&#xD;
      oxygen therapy in patients with extubation failure was evaluated.&#xD;
&#xD;
      A clinical trial was conducted that included patients who underwent mechanical ventilation&#xD;
      and developed acute respiratory failure after extubation. After extubation failure,&#xD;
      thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients. Medical and surgical patients admitted to intensive care unit with 18 years of age&#xD;
      or older in weaning from their first episode of mechanical ventilation for more than 24 hours&#xD;
      were included. Patients with structural neurological disorder, acute toxic-metabolic&#xD;
      neurological encephalopathy with neurological deficit [estimated by a Glasgow Coma Score &lt;14&#xD;
      points] at the time of weaning, neuromuscular disease, chronic obstructive pulmonary disease&#xD;
      receiving non-invasive ventilation, limitation of life support therapy during their&#xD;
      admission, tracheostomized patients, spinal cord injuries, scheduled surgical procedure&#xD;
      during the 48 hours following extubation, intensive care unit readmission, transfer to&#xD;
      another centre or a contraindication to non-invasive ventilation were excluded.&#xD;
&#xD;
      Weaning protocol. The beginning of weaning was considered when patients were conscious,&#xD;
      without pain, connected to mechanical ventilation in pressure support ventilation mode,&#xD;
      fraction of inspired oxygen ≤0.5, positive end-expiratory pressure +5cmH20, dopamine ≤5&#xD;
      mcgr/kg/min or noradrenaline ≤0.2 mcgr/kg/min, temperature &lt;38ºC and absence of metabolic&#xD;
      acidosis. Weaning consisted of a spontaneous breathing trial, which is routinely performed in&#xD;
      our unit with a T-tube connected to an oxygen source . The following conditions indicated a&#xD;
      successful spontaneous breathing trial: oxygen partial pressure ≥60 mmHg or transcutaneous&#xD;
      oxygen saturation&gt;90% with fraction of inspired oxygen &lt;0.5, carbon dioxide partial pressure&#xD;
      &lt;50 mmHg (or an increase &lt;8 mmHg), pH &gt;7.32, respiratory rate &lt;35 bpm (or an increase &lt;50%),&#xD;
      heart rate &lt;140 bpm (or an increase &lt;20%), systolic blood pressure &lt;180 mmHg, and absence of&#xD;
      cardiac arrhythmias after a minimum period of 30-120 min. Once the test was completed,&#xD;
      extubation and subsequent placement of a Venturi oxygen mask with 0.3-0.4 fraction of&#xD;
      inspired oxygen was performed. The physician in charge was responsible for the process of&#xD;
      removal of mechanical ventilation and subsequent extubation. In the case of T-tube test&#xD;
      failure, the patient was reconnected to the ventilator. Patient who presented clinical&#xD;
      deterioration within 48 hours after extubation (work of breathing, use of accessory muscles,&#xD;
      paradoxical breathing) and/or respiratory-gasometric deterioration [respiratory rate &gt;25 bpm&#xD;
      or increase of &gt;50% with respect to the baseline respiratory rate, oxygen partial pressure&#xD;
      &lt;65 mmHg, carbon dioxide partial pressure &gt;45 mmHg or pH &lt;7.33) [19] and who were candidates&#xD;
      for non-invasive ventilation were included in the study. Extubation failure was classified as&#xD;
      follows: 1) Acute respiratory failure secondary to airway problems: obstruction of the upper&#xD;
      airway and aspiration or excess of secretions; 2) Acute respiratory failure not dependent of&#xD;
      the airway: acute pulmonary oedema, congestive heart failure, hypoxemic and/or hypercapnic&#xD;
      acute respiratory failure, encephalopathy and others (digestive bleeding, shock, etc.).&#xD;
      Patients who required immediate reintubation after extubation failure were not included.&#xD;
&#xD;
      After confirming extubation failure and the possibility of eligibility to participate in the&#xD;
      study, the patient was assigned to a group (non-invasive ventilation group or oxygen group)&#xD;
      through the opening of a sealed envelope. Previously, a simple randomisation by a&#xD;
      computerised system had been performed by a physician not involved in the study.&#xD;
&#xD;
      Non-invasive ventilation. BiPAP Vision and continuous positive airway pressure devices were&#xD;
      used. For the BiPAP Vision, oronasal and facial masks and an active humidification system&#xD;
      were used. Procedure: Once the patient was informed of the procedure, the type of mask was&#xD;
      selected according to the clinical situation and anatomy of the patient, and the harness was&#xD;
      placed. Ventilation was initiated with progressive levels of inspiratory positive airway&#xD;
      pressure and expiratory positive airway pressure until a minimum inspiratory positive airway&#xD;
      pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved&#xD;
      in the first hour. The rise time was 0.1-0.2 seconds. Continuous positive airway pressure. A&#xD;
      continuous positive airway pressure device was used through the oronasal mask on the patient.&#xD;
      The minimum initial positive end-expiratory pressure level was 5 cmH2O, with progressive&#xD;
      increases up to 10-15 cmH2O. The objective pressures of both devices were set to reduce&#xD;
      dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. The&#xD;
      fraction of inspired oxygen was increased in both devices until a transcutaneous oxygen&#xD;
      saturation of 94-96% was achieved. Once the patient's cooperation and sufficient adaptability&#xD;
      were achieved, the mask was adjusted to the harness with adjustable straps.&#xD;
&#xD;
      Oxygen therapy. The control group received oxygen therapy using a Venturi mask with an&#xD;
      fraction of inspired oxygen up to 0.5 or using a reservoir mask connected to a high-flow&#xD;
      flowmeter with 30 L/min of O2 (estimated fraction of inspired oxygen of 1.0).&#xD;
&#xD;
      Both non-invasive ventilation/continuous positive airway pressure and oxygen therapy were&#xD;
      maintained continuously (except for hygiene or oral intake) until the patient exhibited&#xD;
      improvement from the clinical and/or gasometric perspective. Withdrawal of non-invasive&#xD;
      ventilation/continuous positive airway pressure was performed progressively with reduction of&#xD;
      inspiratory airway pressure/expiratory positive airway pressure or positive end-expiratory&#xD;
      pressure levels until complete disconnection of non-invasive ventilation. In both groups&#xD;
      (study and control), after improvement, the fraction of inspired oxygen of the Venturi mask&#xD;
      was set to 0.3-0.4. The criteria for failure of both non-invasive ventilation and oxygen&#xD;
      therapy were: absence of clinical improvement (respiratory rate&gt;35 bpm, use of accessory&#xD;
      muscles, thoracoabdominal asynchrony, encephalopathy) or deterioration of oxygenation&#xD;
      (decrease in oxygen partial pressure or in oxygen partial pressure to fraction of inspired&#xD;
      oxygen ratio), haemodynamic (noradrenaline &gt;0.5 mcgr/kg/min) or ventilation (increase in&#xD;
      carbon dioxide partial pressure and decrease in pH) parameters. Modifications of fraction of&#xD;
      inspired oxygen and inspiratory positive airway pressure/expiratory positive airway pressure&#xD;
      or positive end-expiratory pressure levels, as well as the time of orotracheal intubation&#xD;
      were performed according to the criteria of the physician. All patients received aspiration&#xD;
      of secretions, postural changes, incentive spirometry and bronchodilators.&#xD;
&#xD;
      Parameters analysed. After inclusion in the study, demographic data, the reason of mechanical&#xD;
      ventilation, severity according to the Simplified Acute Physiology Score 3, organ failure&#xD;
      according to the Sequential Organ Failure Assessment scale (both of them at intensive care&#xD;
      unit admission) and comorbidities were recorded. The duration both of mechanical ventilation&#xD;
      until the first extubation and time of spontaneous breathing trial were measured.&#xD;
      Neurological variables (Glasgow Coma Score), haemodynamic variables [systolic blood pressure,&#xD;
      diastolic blood pressure, mean blood pressure, heart rate], respiratory variables&#xD;
      (respiratory rate, transcutaneous oxygen saturation) and blood gases (oxygen partial&#xD;
      pressure, fraction of inspired oxygen, oxygen partial pressure to fraction of inspired oxygen&#xD;
      ratio, carbon dioxide partial pressure, pH, bicarbonate and lactic acid) were recorded during&#xD;
      the T-test of patients eligible to participate in the study and later, when they presented&#xD;
      acute respiratory failure due to extubation failure. Similarly, ventilatory parameters were&#xD;
      recorded during the 1st,2nd, and 8th hours of randomisation. Time from extubation to acute&#xD;
      respiratory failure extubation failure was recorded. After extubation failure, the following&#xD;
      variables were recorded: reintubation, tracheostomy, organ failure (cardiovascular,&#xD;
      coagulation, renal, liver, neurological) using the Sequential Organ Failure Assessment scale&#xD;
      and infectious complications (pneumonia or tracheobronchitis associated to mechanical&#xD;
      ventilation, urinary tract infection, bacteraemia) were determined. Also the duration both of&#xD;
      non-invasive ventilation. and oxygen therapy and globally of mechanical ventilation, were&#xD;
      calculated. The mortality rates in the intensive care unit, in the hospital, and at 90 days&#xD;
      were determined.&#xD;
&#xD;
      Sample size. Based on previous results, it was considered that the need for intubation could&#xD;
      be reduced by 35%. The estimated sample size was 30 patients in each group [NIV group vs&#xD;
      oxygen therapy] with a confidence interval [1-α] of 95% and power [1-β] of 80%. Comparative&#xD;
      analyses were conducted using Student's t test or the Mann-Whitney test for the comparisons&#xD;
      of quantitative variables for parametric and non-parametric characteristics, respectively.&#xD;
      For qualitative variables, chi-square statistic or Fisher's exact test were used. Differences&#xD;
      were considered significant if P &lt;0.05. A per protocol analysis was performed. Multivariate&#xD;
      analysis for repeated measures (with Bonferroni's correction) was performed with the aim of&#xD;
      studying the influence either of NIV or oxygen therapy on respiratory parameters. The&#xD;
      cumulative probability of survival was assessed using a Kaplan-Meier estimation of survival&#xD;
      and a log-rank test to compare the two groups. The data were analysed using the statistical&#xD;
      package SPSS 20.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 29, 2009</start_date>
  <completion_date type="Actual">September 4, 2016</completion_date>
  <primary_completion_date type="Actual">June 4, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>STUDY GROUP: Non-invasive ventilation using BiPAP Vision and continuous positive airway pressure (CPAP) systems CONTROL GROUP: Oxygen therapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Intubation</measure>
    <time_frame>from randomization to 1 week</time_frame>
    <description>Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Tracheotomy</measure>
    <time_frame>from randomization to 3 weeks</time_frame>
    <description>Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit Length of Stay</measure>
    <time_frame>From intensive care unit admission to 2 months</time_frame>
    <description>Duration of stay at intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>From hospital admission to 3 months</time_frame>
    <description>Duration of stay at hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy</measure>
    <time_frame>From randomization to one week</time_frame>
    <description>Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Global Mechanical Ventilation</measure>
    <time_frame>From start of mechanical ventilation to one month</time_frame>
    <description>Duration of mechanical ventilation until unsupported ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Intensive Care Unit Mortality</measure>
    <time_frame>From intensive care unit admission to 2 months</time_frame>
    <description>Mortality during intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Hospital Mortality</measure>
    <time_frame>From hospital admission to 3 months</time_frame>
    <description>Mortality during hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of 90 Days Mortality</measure>
    <time_frame>90 days after randomization</time_frame>
    <description>Mortality at 90 days after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Ventilator Associated Pneumonia</measure>
    <time_frame>From start of mechanical ventilation to 2 months</time_frame>
    <description>Percentage of participants with lung infection during intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Urinary Tract Infection</measure>
    <time_frame>From intensive care unit admission to 2 months</time_frame>
    <description>Percentage of participants with urinary tract infection during intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Bacteremia</measure>
    <time_frame>From intensive care unit admission to 2 months</time_frame>
    <description>Percentage of participants with blood infection during intensive care unit stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Non-invasive mechanical ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Venturi mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive mechanical ventilation</intervention_name>
    <arm_group_label>Non-invasive mechanical ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous positive airway pressure</intervention_name>
    <arm_group_label>Non-invasive mechanical ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Venturi mask</intervention_name>
    <arm_group_label>Venturi mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reservoir mask</intervention_name>
    <arm_group_label>Venturi mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical and surgical ICU patients with 18 years of age or older&#xD;
&#xD;
          -  First episode of mechanical ventilation for more than 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Structural neurological disorder&#xD;
&#xD;
          -  Acute toxic-metabolic neurological encephalopathy with neurological deficit [estimated&#xD;
             by a Glasgow Coma Score (GCS) &lt;14 points] at the time of weaning&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease (COPD) receiving NIV&#xD;
&#xD;
          -  Limitation of life support therapy during their admission&#xD;
&#xD;
          -  Tracheostomized patients&#xD;
&#xD;
          -  Spinal cord injuries&#xD;
&#xD;
          -  Scheduled surgical procedure during the 48 hours following extubation&#xD;
&#xD;
          -  Intensive care unit readmission&#xD;
&#xD;
          -  Transfer to another centre&#xD;
&#xD;
          -  Contraindication to non-invasive mechanical ventilation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ALBERTO BELENGUER MUNCHARAZ</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOSPITAL GENERAL UNIVERSITARIO CASTELLON</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitari Castello</name>
      <address>
        <city>Castellón De La Plana</city>
        <state>Castello</state>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <results_first_submitted>February 26, 2019</results_first_submitted>
  <results_first_submitted_qc>February 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 28, 2019</results_first_posted>
  <last_update_submitted>May 26, 2019</last_update_submitted>
  <last_update_submitted_qc>May 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</investigator_affiliation>
    <investigator_full_name>Alberto Belenguer</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Non-invasive mechanical ventilation</keyword>
  <keyword>Oxygen therapy</keyword>
  <keyword>Extubation failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-invasive Mechanical Ventilation</title>
          <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
        </group>
        <group group_id="P2">
          <title>Venturi Mask</title>
          <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>EXCLUSION CRITERIA</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-invasive Mechanical Ventilation</title>
          <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
        </group>
        <group group_id="B2">
          <title>Venturi Mask</title>
          <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>YEARS</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" lower_limit="58" upper_limit="76"/>
                    <measurement group_id="B2" value="62" lower_limit="49" upper_limit="73"/>
                    <measurement group_id="B3" value="64" lower_limit="51" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Intubation</title>
        <description>Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy</description>
        <time_frame>from randomization to 1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Intubation</title>
          <description>Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Tracheotomy</title>
        <description>Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation</description>
        <time_frame>from randomization to 3 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Tracheotomy</title>
          <description>Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensive Care Unit Length of Stay</title>
        <description>Duration of stay at intensive care unit</description>
        <time_frame>From intensive care unit admission to 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Intensive Care Unit Length of Stay</title>
          <description>Duration of stay at intensive care unit</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="9" upper_limit="34"/>
                    <measurement group_id="O2" value="26" lower_limit="13" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Duration of stay at hospital</description>
        <time_frame>From hospital admission to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Duration of stay at hospital</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" lower_limit="26" upper_limit="68"/>
                    <measurement group_id="O2" value="44" lower_limit="30" upper_limit="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy</title>
        <description>Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.</description>
        <time_frame>From randomization to one week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy</title>
          <description>Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.</description>
          <units>HOURS</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="22" upper_limit="80"/>
                    <measurement group_id="O2" value="10" lower_limit="2" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Global Mechanical Ventilation</title>
        <description>Duration of mechanical ventilation until unsupported ventilation</description>
        <time_frame>From start of mechanical ventilation to one month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Global Mechanical Ventilation</title>
          <description>Duration of mechanical ventilation until unsupported ventilation</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="7" upper_limit="22"/>
                    <measurement group_id="O2" value="14" lower_limit="7" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Intensive Care Unit Mortality</title>
        <description>Mortality during intensive care unit stay</description>
        <time_frame>From intensive care unit admission to 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Intensive Care Unit Mortality</title>
          <description>Mortality during intensive care unit stay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Hospital Mortality</title>
        <description>Mortality during hospital stay</description>
        <time_frame>From hospital admission to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Hospital Mortality</title>
          <description>Mortality during hospital stay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of 90 Days Mortality</title>
        <description>Mortality at 90 days after randomization</description>
        <time_frame>90 days after randomization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of 90 Days Mortality</title>
          <description>Mortality at 90 days after randomization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Ventilator Associated Pneumonia</title>
        <description>Percentage of participants with lung infection during intensive care unit stay</description>
        <time_frame>From start of mechanical ventilation to 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Ventilator Associated Pneumonia</title>
          <description>Percentage of participants with lung infection during intensive care unit stay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Urinary Tract Infection</title>
        <description>Percentage of participants with urinary tract infection during intensive care unit stay</description>
        <time_frame>From intensive care unit admission to 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Urinary Tract Infection</title>
          <description>Percentage of participants with urinary tract infection during intensive care unit stay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Bacteremia</title>
        <description>Percentage of participants with blood infection during intensive care unit stay</description>
        <time_frame>From intensive care unit admission to 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-invasive Mechanical Ventilation</title>
            <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
          </group>
          <group group_id="O2">
            <title>Venturi Mask</title>
            <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Bacteremia</title>
          <description>Percentage of participants with blood infection during intensive care unit stay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Non-invasive Mechanical Ventilation</title>
          <description>Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.&#xD;
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Non-invasive mechanical ventilation&#xD;
Continuous positive airway pressure</description>
        </group>
        <group group_id="E2">
          <title>Venturi Mask</title>
          <description>For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.&#xD;
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.&#xD;
Venturi mask&#xD;
Reservoir mask</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Long period of inclusion of patients due to being a single-centre study, strict exclusion criteria; low extubation failure probably due to prolongation of MV until extubation; Lastly, direct use of NIV in eligible patients after extubation failure.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. ALBERTO BELENGUER MUNCHARAZ</name_or_title>
      <organization>HOSPITAL GENERAL UNIVERSITARIO DE CASTELLÓN</organization>
      <phone>96472500</phone>
      <email>belengueralberto8@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03832387
org study id: HGCS03
nct id: NCT03832387
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after
      extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus
      oxygen therapy in patients with extubation failure was evaluated.

      A clinical trial was conducted that included patients who underwent mechanical ventilation
      and developed acute respiratory failure after extubation. After extubation failure,
      thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.
Patients. Medical and surgical patients admitted to intensive care unit with 18 years of age
      or older in weaning from their first episode of mechanical ventilation for more than 24 hours
      were included. Patients with structural neurological disorder, acute toxic-metabolic
      neurological encephalopathy with neurological deficit [estimated by a Glasgow Coma Score <14
      points] at the time of weaning, neuromuscular disease, chronic obstructive pulmonary disease
      receiving non-invasive ventilation, limitation of life support therapy during their
      admission, tracheostomized patients, spinal cord injuries, scheduled surgical procedure
      during the 48 hours following extubation, intensive care unit readmission, transfer to
      another centre or a contraindication to non-invasive ventilation were excluded.

      Weaning protocol. The beginning of weaning was considered when patients were conscious,
      without pain, connected to mechanical ventilation in pressure support ventilation mode,
      fraction of inspired oxygen ≤0.5, positive end-expiratory pressure +5cmH20, dopamine ≤5
      mcgr/kg/min or noradrenaline ≤0.2 mcgr/kg/min, temperature <38ºC and absence of metabolic
      acidosis. Weaning consisted of a spontaneous breathing trial, which is routinely performed in
      our unit with a T-tube connected to an oxygen source . The following conditions indicated a
      successful spontaneous breathing trial: oxygen partial pressure ≥60 mmHg or transcutaneous
      oxygen saturation>90% with fraction of inspired oxygen <0.5, carbon dioxide partial pressure
      <50 mmHg (or an increase <8 mmHg), pH >7.32, respiratory rate <35 bpm (or an increase <50%),
      heart rate <140 bpm (or an increase <20%), systolic blood pressure <180 mmHg, and absence of
      cardiac arrhythmias after a minimum period of 30-120 min. Once the test was completed,
      extubation and subsequent placement of a Venturi oxygen mask with 0.3-0.4 fraction of
      inspired oxygen was performed. The physician in charge was responsible for the process of
      removal of mechanical ventilation and subsequent extubation. In the case of T-tube test
      failure, the patient was reconnected to the ventilator. Patient who presented clinical
      deterioration within 48 hours after extubation (work of breathing, use of accessory muscles,
      paradoxical breathing) and/or respiratory-gasometric deterioration [respiratory rate >25 bpm
      or increase of >50% with respect to the baseline respiratory rate, oxygen partial pressure
      <65 mmHg, carbon dioxide partial pressure >45 mmHg or pH <7.33) [19] and who were candidates
      for non-invasive ventilation were included in the study. Extubation failure was classified as
      follows: 1) Acute respiratory failure secondary to airway problems: obstruction of the upper
      airway and aspiration or excess of secretions; 2) Acute respiratory failure not dependent of
      the airway: acute pulmonary oedema, congestive heart failure, hypoxemic and/or hypercapnic
      acute respiratory failure, encephalopathy and others (digestive bleeding, shock, etc.).
      Patients who required immediate reintubation after extubation failure were not included.

      After confirming extubation failure and the possibility of eligibility to participate in the
      study, the patient was assigned to a group (non-invasive ventilation group or oxygen group)
      through the opening of a sealed envelope. Previously, a simple randomisation by a
      computerised system had been performed by a physician not involved in the study.

      Non-invasive ventilation. BiPAP Vision and continuous positive airway pressure devices were
      used. For the BiPAP Vision, oronasal and facial masks and an active humidification system
      were used. Procedure: Once the patient was informed of the procedure, the type of mask was
      selected according to the clinical situation and anatomy of the patient, and the harness was
      placed. Ventilation was initiated with progressive levels of inspiratory positive airway
      pressure and expiratory positive airway pressure until a minimum inspiratory positive airway
      pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved
      in the first hour. The rise time was 0.1-0.2 seconds. Continuous positive airway pressure. A
      continuous positive airway pressure device was used through the oronasal mask on the patient.
      The minimum initial positive end-expiratory pressure level was 5 cmH2O, with progressive
      increases up to 10-15 cmH2O. The objective pressures of both devices were set to reduce
      dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. The
      fraction of inspired oxygen was increased in both devices until a transcutaneous oxygen
      saturation of 94-96% was achieved. Once the patient's cooperation and sufficient adaptability
      were achieved, the mask was adjusted to the harness with adjustable straps.

      Oxygen therapy. The control group received oxygen therapy using a Venturi mask with an
      fraction of inspired oxygen up to 0.5 or using a reservoir mask connected to a high-flow
      flowmeter with 30 L/min of O2 (estimated fraction of inspired oxygen of 1.0).

      Both non-invasive ventilation/continuous positive airway pressure and oxygen therapy were
      maintained continuously (except for hygiene or oral intake) until the patient exhibited
      improvement from the clinical and/or gasometric perspective. Withdrawal of non-invasive
      ventilation/continuous positive airway pressure was performed progressively with reduction of
      inspiratory airway pressure/expiratory positive airway pressure or positive end-expiratory
      pressure levels until complete disconnection of non-invasive ventilation. In both groups
      (study and control), after improvement, the fraction of inspired oxygen of the Venturi mask
      was set to 0.3-0.4. The criteria for failure of both non-invasive ventilation and oxygen
      therapy were: absence of clinical improvement (respiratory rate>35 bpm, use of accessory
      muscles, thoracoabdominal asynchrony, encephalopathy) or deterioration of oxygenation
      (decrease in oxygen partial pressure or in oxygen partial pressure to fraction of inspired
      oxygen ratio), haemodynamic (noradrenaline >0.5 mcgr/kg/min) or ventilation (increase in
      carbon dioxide partial pressure and decrease in pH) parameters. Modifications of fraction of
      inspired oxygen and inspiratory positive airway pressure/expiratory positive airway pressure
      or positive end-expiratory pressure levels, as well as the time of orotracheal intubation
      were performed according to the criteria of the physician. All patients received aspiration
      of secretions, postural changes, incentive spirometry and bronchodilators.

      Parameters analysed. After inclusion in the study, demographic data, the reason of mechanical
      ventilation, severity according to the Simplified Acute Physiology Score 3, organ failure
      according to the Sequential Organ Failure Assessment scale (both of them at intensive care
      unit admission) and comorbidities were recorded. The duration both of mechanical ventilation
      until the first extubation and time of spontaneous breathing trial were measured.
      Neurological variables (Glasgow Coma Score), haemodynamic variables [systolic blood pressure,
      diastolic blood pressure, mean blood pressure, heart rate], respiratory variables
      (respiratory rate, transcutaneous oxygen saturation) and blood gases (oxygen partial
      pressure, fraction of inspired oxygen, oxygen partial pressure to fraction of inspired oxygen
      ratio, carbon dioxide partial pressure, pH, bicarbonate and lactic acid) were recorded during
      the T-test of patients eligible to participate in the study and later, when they presented
      acute respiratory failure due to extubation failure. Similarly, ventilatory parameters were
      recorded during the 1st,2nd, and 8th hours of randomisation. Time from extubation to acute
      respiratory failure extubation failure was recorded. After extubation failure, the following
      variables were recorded: reintubation, tracheostomy, organ failure (cardiovascular,
      coagulation, renal, liver, neurological) using the Sequential Organ Failure Assessment scale
      and infectious complications (pneumonia or tracheobronchitis associated to mechanical
      ventilation, urinary tract infection, bacteraemia) were determined. Also the duration both of
      non-invasive ventilation. and oxygen therapy and globally of mechanical ventilation, were
      calculated. The mortality rates in the intensive care unit, in the hospital, and at 90 days
      were determined.

      Sample size. Based on previous results, it was considered that the need for intubation could
      be reduced by 35%. The estimated sample size was 30 patients in each group [NIV group vs
      oxygen therapy] with a confidence interval [1-α] of 95% and power [1-β] of 80%. Comparative
      analyses were conducted using Student's t test or the Mann-Whitney test for the comparisons
      of quantitative variables for parametric and non-parametric characteristics, respectively.
      For qualitative variables, chi-square statistic or Fisher's exact test were used. Differences
      were considered significant if P <0.05. A per protocol analysis was performed. Multivariate
      analysis for repeated measures (with Bonferroni's correction) was performed with the aim of
      studying the influence either of NIV or oxygen therapy on respiratory parameters. The
      cumulative probability of survival was assessed using a Kaplan-Meier estimation of survival
      and a log-rank test to compare the two groups. The data were analysed using the statistical
      package SPSS 20.0.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: STUDY GROUP: Non-invasive ventilation using BiPAP Vision and continuous positive airway pressure (CPAP) systems CONTROL GROUP: Oxygen therapy
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Intubation
time frame: from randomization to 1 week
description: Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy
measure: Rate of Tracheotomy
time frame: from randomization to 3 weeks
description: Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation
measure: Intensive Care Unit Length of Stay
time frame: From intensive care unit admission to 2 months
description: Duration of stay at intensive care unit
measure: Hospital Length of Stay
time frame: From hospital admission to 3 months
description: Duration of stay at hospital
measure: Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy
time frame: From randomization to one week
description: Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.
measure: Duration of Global Mechanical Ventilation
time frame: From start of mechanical ventilation to one month
description: Duration of mechanical ventilation until unsupported ventilation
measure: Rate of Intensive Care Unit Mortality
time frame: From intensive care unit admission to 2 months
description: Mortality during intensive care unit stay
measure: Rate of Hospital Mortality
time frame: From hospital admission to 3 months
description: Mortality during hospital stay
measure: Rate of 90 Days Mortality
time frame: 90 days after randomization
description: Mortality at 90 days after randomization
measure: Rate of Ventilator Associated Pneumonia
time frame: From start of mechanical ventilation to 2 months
description: Percentage of participants with lung infection during intensive care unit stay
measure: Rate of Urinary Tract Infection
time frame: From intensive care unit admission to 2 months
description: Percentage of participants with urinary tract infection during intensive care unit stay
measure: Rate of Bacteremia
time frame: From intensive care unit admission to 2 months
description: Percentage of participants with blood infection during intensive care unit stay
arm group label: Non-invasive mechanical ventilation
arm group type: Experimental
description: Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.
The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.
arm group label: Venturi mask
arm group type: Active Comparator
description: For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.
The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.
intervention type: Device
intervention name: Non-invasive mechanical ventilation
arm group label: Non-invasive mechanical ventilation
intervention type: Device
intervention name: Continuous positive airway pressure
arm group label: Non-invasive mechanical ventilation
intervention type: Device
intervention name: Venturi mask
arm group label: Venturi mask
intervention type: Device
intervention name: Reservoir mask
arm group label: Venturi mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ALBERTO BELENGUER MUNCHARAZ
role: Principal Investigator
affiliation: HOSPITAL GENERAL UNIVERSITARIO CASTELLON
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
investigator full name: Alberto Belenguer
investigator title: Principal investigator
mesh term: Respiratory Insufficiency
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Long period of inclusion of patients due to being a single-centre study, strict exclusion criteria; low extubation failure probably due to prolongation of MV until extubation; Lastly, direct use of NIV in eligible patients after extubation failure.
point of contact: 