<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/NCT04402320</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-19-20</org_study_id>
    <nct_id>NCT04402320</nct_id>
  </id_info>
  <brief_title>Non Invasive and Invasive Ventilation Post Extubation</brief_title>
  <official_title>Comparative Study Between Usage of NIV Versus MV for One Hour After Fulfillment of Weaning Criteria From Ventilation on Re-intubation in Post-traumatic ARDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdul Aziz Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdul Aziz Specialist Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients and methods: It is a prospective double blind study done on total 300 patients.&#xD;
      Admitted with respiratory failure ARDS due to severe lung contusion. All of them selected to&#xD;
      be ventilated for one week or more. Patients were randomly allocated in one of three groups&#xD;
      each group contain 100 patients. Group A considered control extubated and follow our routine&#xD;
      protocol, patients of group B reconnected to mechanical ventilation before extubation for one&#xD;
      hour. patients of Group C extubated and immediately connected to NIV with BIPAP mode for 1&#xD;
      hour every 12 hours for 24 hours. Results: There was significant reduction in the number of&#xD;
      patients had deterioration in conscious level in all the duration of the study in patients of&#xD;
      both groups B and C compared to group A. Also significant reduction in the number of patients&#xD;
      had deterioration in clinical parameters of respiration in all the duration of the study in&#xD;
      patients of both groups B and C compared to group A as regards high respiratory rate,&#xD;
      desaturation and development of hyperdynamic circulation (tachycardia and hypertension).&#xD;
      significant reduction in the number of patients had multiple quadrant parenchymatous&#xD;
      infiltration in all the duration of the study in patients of both groups B and C compared to&#xD;
      group A. significant reduction in the number of patients had marked limitation to FEV1, FVC&#xD;
      and MVV in all the duration of the study in patients of both groups B and C compared to group&#xD;
      A. Conclusion: Use of either NIV every 12 hours for 24 hours or MV for one hour after&#xD;
      fulfillment of weaning criteria reduces reintubation and post-extubation respiratory failure&#xD;
      and decrease the ICU stay in critically ill patients with resolving ARDS due to severe lung&#xD;
      trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective double-blind study done on total 300 patients. Admitted to King Abdulaziz&#xD;
      specialist hospital in Taif, KSA. Between April 2019 and April 2020 with respiratory failure&#xD;
      ARDS due to severe lung contusion with these criteria: hypoxic index less than 200, bilateral&#xD;
      parenchymatous lung infiltrate, no any acute cardiac insult, failed to maintain SPO2 more&#xD;
      than 90% with Non-Invasive Ventilation (NIV) or need of continuous NIV to maintain the&#xD;
      previous saturation. This selected ARDS was due to lung contusion which diagnosed by&#xD;
      Computerized tomography of the chest following chest trauma. All of them selected to be&#xD;
      ventilated for one week or more and only those who showed full criteria of weaning from the&#xD;
      ventilator enrolled in our study. Our criteria of weaning include fully conscious patients,&#xD;
      hemodynamically stable without any inotropic support, hypoxic index(PAO2/FIO2) more than 200&#xD;
      calculated from the arterial blood gases (ABG), bicarbonate level in arterial blood more than&#xD;
      20 mmol/l, hemoglobin level more than 10 gm%, chest X ray less than one quadrant&#xD;
      parenchymatous infiltration in each lung on Murray score of chest Xray, rapid shallow&#xD;
      breathing index &lt;105. Patients were randomly allocated in one of three groups each group&#xD;
      contain 100 patients. Randomization sequence was created using Excel 2007 (Microsoft,&#xD;
      Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent&#xD;
      doctor. In this way, sequence generation and type of randomization can be expressed at the&#xD;
      same time. Patients of group A extubated and followed our routine protocol of management post&#xD;
      extubation which include Nebulization with Ventolin and epinephrine racemic every 8 hours for&#xD;
      48 hours, chest physical therapy (CPT) every 6 hours for 48 hours include clapping percussion&#xD;
      with mechanical vibration and suction plus huffing or coughing and postural drainage if there&#xD;
      was atelectasis seen by our routine chest X ray. Patients of group B reconnected to&#xD;
      mechanical ventilation before extubation for one hour with sedation with midazolam 3-5&#xD;
      milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation&#xD;
      Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and&#xD;
      patients awaked. Patient put on mechanical ventilation (MV) with the following parameters,&#xD;
      FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate&#xD;
      14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our&#xD;
      previous protocol without the use of NIV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>number of patients re-intubated within 48 hours and shorten the duration of ICU stay</measure>
    <time_frame>48 hours</time_frame>
    <description>monitoring hemodynamics, oxygenation, and conscious level in the studied duration</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Respiratory Failure With Hypoxia</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>extubated and weaning from the ventilator and followed our routine protocol of management post extubation without mechanical ventilation or BIPAP machine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Invasive ventilation group</arm_group_label>
    <description>reconnected to mechanical ventilator before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use of NIV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non invasive ventilation group</arm_group_label>
    <description>following the same previous protocol done after extubation with immediate connection to NIV with BIPAP mode for 1 hour and repeated every 12hours for 48 hours, BIPAP adjusted in our study by FIO2 40%, PEEP 8 cmH2O, Pressure support of 15 cmH2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>reconnected to mechanical ventilation before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Invasive ventilation group</arm_group_label>
    <arm_group_label>non invasive ventilation group</arm_group_label>
    <other_name>dormicum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ventilator</intervention_name>
    <description>reconnected to mechanical ventilation before extubation for one hour with sedation</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Invasive ventilation group</arm_group_label>
    <arm_group_label>non invasive ventilation group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        on total 300 patients. Admitted to King Abdulaziz specialist hospital in Taif, KSA. Between&#xD;
        April 2019 and April 2020 with respiratory failure ARDS due to severe lung contusion with&#xD;
        these criteria: hypoxic index less than 200, bilateral parenchymatous lung infiltrate, no&#xD;
        any acute cardiac insult, failed to maintain SPO2 more than 90% with Non-Invasive&#xD;
        Ventilation (NIV) or need of continuous NIV to maintain the previous saturation. This&#xD;
        selected ARDS was due to lung contusion which diagnosed by Computerized tomography of the&#xD;
        chest following chest trauma. All of them selected to be ventilated for one week or more&#xD;
        and only those who showed full criteria of weaning from the ventilator enrolled in our&#xD;
        study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  respiratory failure ARDS due to severe lung contusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  post arrest, deeply comatosed patients and children below 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>adult only 18-65 years</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King abd el Aziz specialist hospital</name>
      <address>
        <city>Ta'if</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non invasive ventilation invasive ventilation ARDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>see if both iv or niv after fullfilling the criteria of extubation in ARDS patients can prevent reintubation</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04402320
org study id: ICU-19-20
nct id: NCT04402320
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
Patients and methods: It is a prospective double blind study done on total 300 patients.
      Admitted with respiratory failure ARDS due to severe lung contusion. All of them selected to
      be ventilated for one week or more. Patients were randomly allocated in one of three groups
      each group contain 100 patients. Group A considered control extubated and follow our routine
      protocol, patients of group B reconnected to mechanical ventilation before extubation for one
      hour. patients of Group C extubated and immediately connected to NIV with BIPAP mode for 1
      hour every 12 hours for 24 hours. Results: There was significant reduction in the number of
      patients had deterioration in conscious level in all the duration of the study in patients of
      both groups B and C compared to group A. Also significant reduction in the number of patients
      had deterioration in clinical parameters of respiration in all the duration of the study in
      patients of both groups B and C compared to group A as regards high respiratory rate,
      desaturation and development of hyperdynamic circulation (tachycardia and hypertension).
      significant reduction in the number of patients had multiple quadrant parenchymatous
      infiltration in all the duration of the study in patients of both groups B and C compared to
      group A. significant reduction in the number of patients had marked limitation to FEV1, FVC
      and MVV in all the duration of the study in patients of both groups B and C compared to group
      A. Conclusion: Use of either NIV every 12 hours for 24 hours or MV for one hour after
      fulfillment of weaning criteria reduces reintubation and post-extubation respiratory failure
      and decrease the ICU stay in critically ill patients with resolving ARDS due to severe lung
      trauma.
It is a prospective double-blind study done on total 300 patients. Admitted to King Abdulaziz
      specialist hospital in Taif, KSA. Between April 2019 and April 2020 with respiratory failure
      ARDS due to severe lung contusion with these criteria: hypoxic index less than 200, bilateral
      parenchymatous lung infiltrate, no any acute cardiac insult, failed to maintain SPO2 more
      than 90% with Non-Invasive Ventilation (NIV) or need of continuous NIV to maintain the
      previous saturation. This selected ARDS was due to lung contusion which diagnosed by
      Computerized tomography of the chest following chest trauma. All of them selected to be
      ventilated for one week or more and only those who showed full criteria of weaning from the
      ventilator enrolled in our study. Our criteria of weaning include fully conscious patients,
      hemodynamically stable without any inotropic support, hypoxic index(PAO2/FIO2) more than 200
      calculated from the arterial blood gases (ABG), bicarbonate level in arterial blood more than
      20 mmol/l, hemoglobin level more than 10 gm%, chest X ray less than one quadrant
      parenchymatous infiltration in each lung on Murray score of chest Xray, rapid shallow
      breathing index <105. Patients were randomly allocated in one of three groups each group
      contain 100 patients. Randomization sequence was created using Excel 2007 (Microsoft,
      Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent
      doctor. In this way, sequence generation and type of randomization can be expressed at the
      same time. Patients of group A extubated and followed our routine protocol of management post
      extubation which include Nebulization with Ventolin and epinephrine racemic every 8 hours for
      48 hours, chest physical therapy (CPT) every 6 hours for 48 hours include clapping percussion
      with mechanical vibration and suction plus huffing or coughing and postural drainage if there
      was atelectasis seen by our routine chest X ray. Patients of group B reconnected to
      mechanical ventilation before extubation for one hour with sedation with midazolam 3-5
      milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation
      Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and
      patients awaked. Patient put on mechanical ventilation (MV) with the following parameters,
      FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate
      14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our
      previous protocol without the use of NIV.
observational model: Cohort
time perspective: Prospective
measure: number of patients re-intubated within 48 hours and shorten the duration of ICU stay
time frame: 48 hours
description: monitoring hemodynamics, oxygenation, and conscious level in the studied duration
arm group label: Control group
description: extubated and weaning from the ventilator and followed our routine protocol of management post extubation without mechanical ventilation or BIPAP machine
arm group label: Invasive ventilation group
description: reconnected to mechanical ventilator before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use of NIV.
arm group label: non invasive ventilation group
description: following the same previous protocol done after extubation with immediate connection to NIV with BIPAP mode for 1 hour and repeated every 12hours for 48 hours, BIPAP adjusted in our study by FIO2 40%, PEEP 8 cmH2O, Pressure support of 15 cmH2O.
intervention type: Drug
intervention name: Midazolam
description: reconnected to mechanical ventilation before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use
arm group label: Control group
arm group label: Invasive ventilation group
arm group label: non invasive ventilation group
other name: dormicum
intervention type: Device
intervention name: ventilator
description: reconnected to mechanical ventilation before extubation for one hour with sedation
arm group label: Control group
arm group label: Invasive ventilation group
arm group label: non invasive ventilation group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: adult only 18-65 years
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Hypoxia
mesh term: Midazolam
sharing ipd: No
ipd description: see if both iv or niv after fullfilling the criteria of extubation in ARDS patients can prevent reintubation