<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/NCT03282552</url>
  </required_header>
  <id_info>
    <org_study_id>NKU Athens</org_study_id>
    <nct_id>NCT03282552</nct_id>
  </id_info>
  <brief_title>High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients</brief_title>
  <official_title>High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients-OPTICAR Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National and Kapodistrian University of Athens</source>
  <oversight_info>
    <has_dmc>Yes</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>
      High flow oxygen therapy has been applied after extubation in cardiac surgery patients with&#xD;
      uncertain efficacy. The current authors plan to conduct a prospective, randomized, controlled&#xD;
      study of nasal high flow therapy (NHF) application with high (60L/min) or low flow (40L/min)&#xD;
      oxygen mixture administration versus standard oxygen treatment (Venturi mask) after&#xD;
      extubation of patients undergoing elective or non-elective cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the past decade, nasal high flow (NHF) has been introduced for oxygen therapy in adults.&#xD;
      Its indications have been expanded, especially in cases of acute hypoxemic respiratory&#xD;
      failure.&#xD;
&#xD;
      The device consists of an air/oxygen blender connected via an active heated humidifier to a&#xD;
      nasal cannula, through a single limb, heated inspiratory circuit. It delivers a fraction of&#xD;
      inspired oxygen (FiO2) from 21% to 100% with a flow rate up to 60 L/min. FiO2 adjustments are&#xD;
      independent of the set flow rate so that the patient is given heated, humidified high-flow&#xD;
      oxygen, with a flow that can be adjusted above the patient's maximum inspiratory flow rate,&#xD;
      thereby increasing confidence about the actual FiO2 being delivered to the patient. These&#xD;
      device characteristics make it more promising in comparison with conventional low- and&#xD;
      high-flow oxygen devices (e.g., nasal cannula, non-rebreathing masks, Venturi masks),&#xD;
      especially in patients with high inspiratory flow rates, such as patients with acute&#xD;
      respiratory failure (ARF).&#xD;
&#xD;
      The benefits arising from application of oxygen with high flow rates via NHF are&#xD;
&#xD;
        1. reduction in the entrainment of room air and thus ensuring higher and more stable FiO2&#xD;
           values,&#xD;
&#xD;
        2. generation of positive airway pressures during expiration as a result of the expiratory&#xD;
           resistance imposed to the patient's exhalation against the continuous high flow of&#xD;
           incoming oxygen gas,&#xD;
&#xD;
        3. improving mucociliary function and clearance of secretion by continuous heating and&#xD;
           humidifying of the administered gas,&#xD;
&#xD;
        4. reducing dead space ventilation and&#xD;
&#xD;
        5. reducing work of breathing. All the aforementioned NHF mechanisms of actions exert&#xD;
           various effects on the respiratory system, including improved gas exchange, lower&#xD;
           respiratory rate and effort and improved lung mechanics which are correlated with more&#xD;
           comfort and less subjective dyspnea.&#xD;
&#xD;
      Respiratory complications after cardiac surgery can affect morbidity and mortality, and&#xD;
      increase the healthcare cost. Advanced age, duration of extracorporeal circulation, history&#xD;
      of significant underlying cardiac or pulmonary disease and phrenic nerve injury are the main&#xD;
      prognostic factors for post cardiac surgery respiratory complications.&#xD;
&#xD;
      Traditionally, low- and high-flow oxygen systems are used to reverse postsurgical respiratory&#xD;
      complications with or without addition of continuous (CPAP) or bi-level (NIV) positive airway&#xD;
      pressure.&#xD;
&#xD;
      NHF might be superior for the prevention or treatment of those respiratory complications,&#xD;
      since it can provide high-flow of heated and hydrated oxygen while the positive airway&#xD;
      pressure created by the high gas flow can recruit alveoli and increase the end-expiratory&#xD;
      lung volume.&#xD;
&#xD;
      Studies applying NHF immediately after extubation in cardiac surgery patients revealed better&#xD;
      oxygenation and less need for advanced methods of respiratory support compared to&#xD;
      conventional oxygen devices , and similar results compared to noninvasive ventilation.&#xD;
      However, Zochios et al, summarized all the available up to date data of NHF compared to&#xD;
      conventional oxygen devices and non-invasive ventilation in patients undergoing&#xD;
      cardiothoracic surgery and they did not find any further benefit by NHF use. The&#xD;
      aforementioned discrepancy could be explained by the differences in the studied populations&#xD;
      and NHF flow settings. The proposed initial flow rate differs among the studies, with some&#xD;
      authors suggesting initial lower flows (35-40 L/min) that will be better tolerated by the&#xD;
      patients and others suggesting initial maximal flows (60 L/min) to rapidly relieve dyspnea&#xD;
      and prevent muscle fatigue.&#xD;
&#xD;
      Aim The primary goal of the study is to evaluate the efficacy of NHF (with initial flows of&#xD;
      60 L/min or 40 L/min) versus conventional oxygen systems on respiratory parameters&#xD;
      (respiratory rate, pO2/ FiO2, spO2, use of accessory muscles, dyspnoea, comfort and tolerance&#xD;
      by using the visual analogue scale) immediately after the extubation of cardiac surgery&#xD;
      patients.&#xD;
&#xD;
      Additional goals of the study are to compare two different initial NHF flows of 60 L/min and&#xD;
      40 L/min, ICU Length of Stay, Hospital Length of Stay, rates of ICU re-admission and&#xD;
      re-intubation and any other respiratory / non-respiratory complications and adverse events.&#xD;
      Moreover, the rate of failure of the initial treatment will be recorded (as a major measure&#xD;
      of treatment efficacy).&#xD;
&#xD;
      Method&#xD;
&#xD;
      This is a prospective, non-blinded, randomized study in post-extubated cardiac surgery&#xD;
      patients. The study population will consist of three patient groups:&#xD;
&#xD;
      The first group (Study Group 1) will include patients on NHF with initial settings of&#xD;
      FiO2=60% and gas flow=60L/min.&#xD;
&#xD;
      The second group (Study Group 2) will include patients on NHF with initial settings of&#xD;
      FiO2=60% and gas flow=40L/min In the third group (control group) all patients will receive&#xD;
      oxygen therapy according to the standard practice of our cardiac ICU department, i.e.,&#xD;
      Venturi mask with FiO2=60% and flow of 15L/min.&#xD;
&#xD;
      Patients in both study groups would be weaned off the NHF as follows; First reducing FiO2&#xD;
      gradually to 50%, and then gradually reducing the gas flow (either from 60l/min or 40/min,&#xD;
      depending on the study group) down to 30l/min, aiming at the final wean-off goal of 20l/min,&#xD;
      unless the attending physician decides to wean-off patient to Venturi mask directly from a&#xD;
      higher gas flow supply (e.g.: 30-25l/min) Treatment failure will be defined as any crossover&#xD;
      from one treatment to another due to patient's respiratory distress and discomfort. To be&#xD;
      more specific, switch of gas flow from 40L/min to 60L/min, crossover from either NHF group to&#xD;
      standard practice (Venturi mask) or need for more advanced respiratory support such as&#xD;
      non-invasive ventilation or invasive mechanical ventilation.&#xD;
&#xD;
      Any implemented treatment would also be defined as &quot;failure&quot; when any irreversible (for at&#xD;
      least 48 hours) FiO2/gas-mixture flow escalation might be needed, either it is being recorded&#xD;
      on Study group 1 &amp; 2 or Control group.&#xD;
&#xD;
      An initial power analysis was based on a predicted, average failure rate of 15% in the 2 NHF&#xD;
      groups and a failure rate of 51% in the control group; this analysis yielded the need for&#xD;
      enrollment of a total of 41 NHF patients and 21 controls for alpha = 0.05 and power=0.80. To&#xD;
      ensure equal numbers of patients in each one of the 2 NHF groups, the authors decided to&#xD;
      actually enroll 42 NHF patients (n=21 for each NHF group) and 21 controls, resulting in a&#xD;
      total enrollment of 63 patients. At one year after study initiation, actual, total enrollment&#xD;
      amounted to 45 patients. At this time point, the Data Monitoring Committee (after confirming&#xD;
      the safe application of the study protocol) recommended the continuation of the study until&#xD;
      the enrollment of 99 patients (n=33 for each one of the 3 groups); the rationale for this was&#xD;
      to compensate for possible dropouts and/or missing data (especially for the secondary and&#xD;
      &quot;other&quot; outcomes). Accordingly, the study was completed with an actual enrollment of 99&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">October 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful weaning (i.e. absence of treatment failure) from Nasal Cannula High Flow Oxygenation post extubation from cardiac surgery within at least 48 hours</measure>
    <time_frame>Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)</time_frame>
    <description>Successful weaning (i.e. absence of treatment failure as further described in methods) would be defined as = 0 when there would be avoided successfully any alternation with other mode of oxygen therapy, or re-intubation, or Non Invasive Ventilation.&#xD;
For all groups: Unsuccessful weaning (i.e. actual treatment failure as further described in methods) would be defined as =1 when there would not be avoided any alternation with other oxygen therapy, re-intubation, Non Invasive Ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).&#xD;
Continuous monitoring and recording of implementation of air flow at 60L/min with Nasal Cannula High Flow Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow of 40 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).&#xD;
Continuous monitoring and recording of implementation of air flow at 40L/min with Nasal Cannula High Flow Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Successful maintenance of Respiratory rate within normal range (12-20/min) would be defined as = 0.&#xD;
Unsuccessful (=1) if exceeds normal range (12-20/min) Continuous monitoring and recording of implementation of Venturi mask FiO2: 60%, 15L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording of pO2/FiO2 ratio with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge</time_frame>
    <description>Continuous monitoring of implementation initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording of pO2/FiO2 ratio with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Continuous monitoring of implementation initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recording of pO2/FiO2 ratio with Venturi mask FiO2: 60%, 15L/min</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Continuous monitoring of implementation Venturi mask, FiO2: 60%, 15L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Successful maintenace of saturation O2 in Hemoglobulin &gt; 92% would be defined as = 0.&#xD;
If saturation O2 &lt; 92 %, then it would be definded as Unsuccessful = 1 Continuous monitoring and recording of implementation initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Successful maintenance of saturation O2 in Hemoglobulin within normal range would be defined as = 0.&#xD;
If saturation O2 &lt; 92 %, then it would be definded as Unsuccessful = 1&#xD;
Continuous monitoring and recording of implementation initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, FiO2: 60%, 15L/min</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Successful maintenance of saturation O2 in Hemoglobulin &gt; 92% would be defined as = 0. If saturation O2 &lt; 92 %, then would be defined as Unsuccessful = 1 .&#xD;
Continuous monitoring and recording of implementation Venturi mask FiO2 : 60%, 15L/min.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobilization of accessory respiratory muscles with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilization and use of accessory respiratory muscles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobilization of accessory respiratory muscles with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilzation and use of accessory respiratory muscles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobilization of accessory respiratory muscles with Venturi mask, FiO2: 60%, 15L/min To record any use of accessory respiratory muscles with Venturi mask , FiO2: 60%, 15L/min</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilzation and use of accessory respiratory muscles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort and tolerance of treatment with Visual Analogue Scale with Venturi mask , FiO2: 60%, 15L/min</measure>
    <time_frame>Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was &lt;48 hours)</time_frame>
    <description>To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Stay in the ICU</measure>
    <time_frame>Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge</time_frame>
    <description>There will be recorded the total length of stay in the ICU since admission post surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of Stay in the Hospital</measure>
    <time_frame>Post ICU admission period up to actual hospital discharge</time_frame>
    <description>There will be recorded the total length of stay in the hospital since ICU admission</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with death in the cardiothoracic ICU post extubation</measure>
    <time_frame>Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge</time_frame>
    <description>There will be recorded the number of participants that will pass away post extubation in the ICU</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with death in the hospital post ICU discharge</measure>
    <time_frame>Post ICU discharge period up to actual hospital discharge</time_frame>
    <description>There will be recorded the number of participants that will pass away post extubation in the hospital , after the ICU discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with Atrial Fibrillation in the ICU post extubation</measure>
    <time_frame>Post ICU admission period up to 48 hours or actual ICU discharge</time_frame>
    <description>There will be recorded the number of participants that will present Atrial Fibrillation post extubation in the ICU</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with any Adverse Events in the ICU</measure>
    <time_frame>Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge</time_frame>
    <description>There will be recorded the number of participants that will present any Adverse Events (respiratory , non-respiratory) post extubation in the ICU</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with any Adverse Events in the Hospital</measure>
    <time_frame>Up to 1 month, or until actual hospital discharge</time_frame>
    <description>There will be recorded the number of participants that will present any Adverse Events (respiratory, non-respiratory) post extubation in the ICU, until hospital discharge.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of participants presenting unsuccessful (failed) implementation of NHFO treatment</measure>
    <time_frame>Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge</time_frame>
    <description>There will be recorded the number of participants that will present failure to comply with the treatment due to failing to maintain their respiratory parameters within normal range, or due to presenting intolerance and discomfort to the implementation of NHFO treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with re-intubation in the ICU</measure>
    <time_frame>Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge</time_frame>
    <description>There will be recorded the number of participants that will be re-intubated due to deterioration of their respiratory parameters.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Hypoxemic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention consists of the implementation of Nasal Cannula High Flow Oxygenation as an oxygen treatment at Study Group 1, whereas oxygen supply was provided via Venturi mask at the standard oxygen patients' treatment.&#xD;
The first Study Group will include patients on Nasal Cannula High Flow Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention consists of the implementation of Nasal Cannula High Flow Oxygenation as an oxygen treatment at Study Group 2, whereas oxygen supply was provided via Venturi mask at the standard oxygen patients' treatment.&#xD;
The second Study Group will include patients on Nasal Cannula High Flow Oxygenation with initial settings of FiO2=60% and gas flow=40L/min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the third group (control group) all patients will receive oxygen treatment according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 15L/min.&#xD;
In this group all patients will receive the usual standard of care, with no other interventions included</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal Cannula High Flow Oxygen</intervention_name>
    <description>Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)</description>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_label>Study Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac ICU adult patients&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  After elective or urgent cardiac surgery&#xD;
&#xD;
          -  Successful Spontaneous Breathing Trial (SBT) with T-piece and FiO2=60%.&#xD;
&#xD;
          -  pO2/ FiO2 &lt;200&#xD;
&#xD;
          -  Hemodynamically stable (160&gt;SAP&gt;90mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obstructive Sleep Apnea Syndrome supported by CPAP&#xD;
&#xD;
          -  COPD, officially diagnosed, respiratory failure with serum blood ph &lt;7,35.&#xD;
&#xD;
          -  Patients with tracheostomy,&#xD;
&#xD;
          -  DNR status,&#xD;
&#xD;
          -  Glasgow Coma Scale score &lt; 13,&#xD;
&#xD;
          -  Insufficient knowledge of Greek Language&#xD;
&#xD;
          -  Visual or hearing impairment.&#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>Spiros Zakynthinos, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Spiridon Mentzelopoulos, AssProfessor</last_name>
    <role>Study Director</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Evangelismos General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Pellegrini JA, Moraes RB, Maccari JG, de Oliveira RP, Savi A, Ribeiro RA, Burns KE, Teixeira C. Spontaneous Breathing Trials With T-Piece or Pressure Support Ventilation. Respir Care. 2016 Dec;61(12):1693-1703. doi: 10.4187/respcare.04816. Epub 2016 Sep 6.</citation>
    <PMID>27601720</PMID>
  </reference>
  <results_reference>
    <citation>Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.</citation>
    <PMID>23857440</PMID>
  </results_reference>
  <results_reference>
    <citation>Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.</citation>
    <PMID>25742321</PMID>
  </results_reference>
  <results_reference>
    <citation>Ritchie JE, Williams AB, Gerard C, Hockey H. Evaluation of a humidified nasal high-flow oxygen system, using oxygraphy, capnography and measurement of upper airway pressures. Anaesth Intensive Care. 2011 Nov;39(6):1103-10. doi: 10.1177/0310057X1103900620.</citation>
    <PMID>22165366</PMID>
  </results_reference>
  <results_reference>
    <citation>Gotera C, Diaz Lobato S, Pinto T, Winck JC. Clinical evidence on high flow oxygen therapy and active humidification in adults. Rev Port Pneumol. 2013 Sep-Oct;19(5):217-27. doi: 10.1016/j.rppneu.2013.03.005. Epub 2013 Jul 8.</citation>
    <PMID>23845744</PMID>
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  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National and Kapodistrian University of Athens</investigator_affiliation>
    <investigator_full_name>Stavros Theologou</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03282552/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03282552
org study id: NKU Athens
nct id: NCT03282552
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
High flow oxygen therapy has been applied after extubation in cardiac surgery patients with
      uncertain efficacy. The current authors plan to conduct a prospective, randomized, controlled
      study of nasal high flow therapy (NHF) application with high (60L/min) or low flow (40L/min)
      oxygen mixture administration versus standard oxygen treatment (Venturi mask) after
      extubation of patients undergoing elective or non-elective cardiac surgery.
Over the past decade, nasal high flow (NHF) has been introduced for oxygen therapy in adults.
      Its indications have been expanded, especially in cases of acute hypoxemic respiratory
      failure.

      The device consists of an air/oxygen blender connected via an active heated humidifier to a
      nasal cannula, through a single limb, heated inspiratory circuit. It delivers a fraction of
      inspired oxygen (FiO2) from 21% to 100% with a flow rate up to 60 L/min. FiO2 adjustments are
      independent of the set flow rate so that the patient is given heated, humidified high-flow
      oxygen, with a flow that can be adjusted above the patient's maximum inspiratory flow rate,
      thereby increasing confidence about the actual FiO2 being delivered to the patient. These
      device characteristics make it more promising in comparison with conventional low- and
      high-flow oxygen devices (e.g., nasal cannula, non-rebreathing masks, Venturi masks),
      especially in patients with high inspiratory flow rates, such as patients with acute
      respiratory failure (ARF).

      The benefits arising from application of oxygen with high flow rates via NHF are

        1. reduction in the entrainment of room air and thus ensuring higher and more stable FiO2
           values,

        2. generation of positive airway pressures during expiration as a result of the expiratory
           resistance imposed to the patient's exhalation against the continuous high flow of
           incoming oxygen gas,

        3. improving mucociliary function and clearance of secretion by continuous heating and
           humidifying of the administered gas,

        4. reducing dead space ventilation and

        5. reducing work of breathing. All the aforementioned NHF mechanisms of actions exert
           various effects on the respiratory system, including improved gas exchange, lower
           respiratory rate and effort and improved lung mechanics which are correlated with more
           comfort and less subjective dyspnea.

      Respiratory complications after cardiac surgery can affect morbidity and mortality, and
      increase the healthcare cost. Advanced age, duration of extracorporeal circulation, history
      of significant underlying cardiac or pulmonary disease and phrenic nerve injury are the main
      prognostic factors for post cardiac surgery respiratory complications.

      Traditionally, low- and high-flow oxygen systems are used to reverse postsurgical respiratory
      complications with or without addition of continuous (CPAP) or bi-level (NIV) positive airway
      pressure.

      NHF might be superior for the prevention or treatment of those respiratory complications,
      since it can provide high-flow of heated and hydrated oxygen while the positive airway
      pressure created by the high gas flow can recruit alveoli and increase the end-expiratory
      lung volume.

      Studies applying NHF immediately after extubation in cardiac surgery patients revealed better
      oxygenation and less need for advanced methods of respiratory support compared to
      conventional oxygen devices , and similar results compared to noninvasive ventilation.
      However, Zochios et al, summarized all the available up to date data of NHF compared to
      conventional oxygen devices and non-invasive ventilation in patients undergoing
      cardiothoracic surgery and they did not find any further benefit by NHF use. The
      aforementioned discrepancy could be explained by the differences in the studied populations
      and NHF flow settings. The proposed initial flow rate differs among the studies, with some
      authors suggesting initial lower flows (35-40 L/min) that will be better tolerated by the
      patients and others suggesting initial maximal flows (60 L/min) to rapidly relieve dyspnea
      and prevent muscle fatigue.

      Aim The primary goal of the study is to evaluate the efficacy of NHF (with initial flows of
      60 L/min or 40 L/min) versus conventional oxygen systems on respiratory parameters
      (respiratory rate, pO2/ FiO2, spO2, use of accessory muscles, dyspnoea, comfort and tolerance
      by using the visual analogue scale) immediately after the extubation of cardiac surgery
      patients.

      Additional goals of the study are to compare two different initial NHF flows of 60 L/min and
      40 L/min, ICU Length of Stay, Hospital Length of Stay, rates of ICU re-admission and
      re-intubation and any other respiratory / non-respiratory complications and adverse events.
      Moreover, the rate of failure of the initial treatment will be recorded (as a major measure
      of treatment efficacy).

      Method

      This is a prospective, non-blinded, randomized study in post-extubated cardiac surgery
      patients. The study population will consist of three patient groups:

      The first group (Study Group 1) will include patients on NHF with initial settings of
      FiO2=60% and gas flow=60L/min.

      The second group (Study Group 2) will include patients on NHF with initial settings of
      FiO2=60% and gas flow=40L/min In the third group (control group) all patients will receive
      oxygen therapy according to the standard practice of our cardiac ICU department, i.e.,
      Venturi mask with FiO2=60% and flow of 15L/min.

      Patients in both study groups would be weaned off the NHF as follows; First reducing FiO2
      gradually to 50%, and then gradually reducing the gas flow (either from 60l/min or 40/min,
      depending on the study group) down to 30l/min, aiming at the final wean-off goal of 20l/min,
      unless the attending physician decides to wean-off patient to Venturi mask directly from a
      higher gas flow supply (e.g.: 30-25l/min) Treatment failure will be defined as any crossover
      from one treatment to another due to patient's respiratory distress and discomfort. To be
      more specific, switch of gas flow from 40L/min to 60L/min, crossover from either NHF group to
      standard practice (Venturi mask) or need for more advanced respiratory support such as
      non-invasive ventilation or invasive mechanical ventilation.

      Any implemented treatment would also be defined as "failure" when any irreversible (for at
      least 48 hours) FiO2/gas-mixture flow escalation might be needed, either it is being recorded
      on Study group 1 & 2 or Control group.

      An initial power analysis was based on a predicted, average failure rate of 15% in the 2 NHF
      groups and a failure rate of 51% in the control group; this analysis yielded the need for
      enrollment of a total of 41 NHF patients and 21 controls for alpha = 0.05 and power=0.80. To
      ensure equal numbers of patients in each one of the 2 NHF groups, the authors decided to
      actually enroll 42 NHF patients (n=21 for each NHF group) and 21 controls, resulting in a
      total enrollment of 63 patients. At one year after study initiation, actual, total enrollment
      amounted to 45 patients. At this time point, the Data Monitoring Committee (after confirming
      the safe application of the study protocol) recommended the continuation of the study until
      the enrollment of 99 patients (n=33 for each one of the 3 groups); the rationale for this was
      to compensate for possible dropouts and/or missing data (especially for the secondary and
      "other" outcomes). Accordingly, the study was completed with an actual enrollment of 99
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Successful weaning (i.e. absence of treatment failure) from Nasal Cannula High Flow Oxygenation post extubation from cardiac surgery within at least 48 hours
time frame: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)
description: Successful weaning (i.e. absence of treatment failure as further described in methods) would be defined as = 0 when there would be avoided successfully any alternation with other mode of oxygen therapy, or re-intubation, or Non Invasive Ventilation.
For all groups: Unsuccessful weaning (i.e. actual treatment failure as further described in methods) would be defined as =1 when there would not be avoided any alternation with other oxygen therapy, re-intubation, Non Invasive Ventilation
measure: Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).
Continuous monitoring and recording of implementation of air flow at 60L/min with Nasal Cannula High Flow Oxygenation
measure: Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow of 40 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Successful maintenance of Respiratory rate within normal range would be defined as = 0. Unsuccessful (=1) if exceeds normal range (12-20/min).
Continuous monitoring and recording of implementation of air flow at 40L/min with Nasal Cannula High Flow Oxygenation
measure: Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Successful maintenance of Respiratory rate within normal range (12-20/min) would be defined as = 0.
Unsuccessful (=1) if exceeds normal range (12-20/min) Continuous monitoring and recording of implementation of Venturi mask FiO2: 60%, 15L/min
measure: Recording of pO2/FiO2 ratio with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge
description: Continuous monitoring of implementation initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
measure: Recording of pO2/FiO2 ratio with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Continuous monitoring of implementation initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation
measure: Recording of pO2/FiO2 ratio with Venturi mask FiO2: 60%, 15L/min
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Continuous monitoring of implementation Venturi mask, FiO2: 60%, 15L/min
measure: Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Successful maintenace of saturation O2 in Hemoglobulin > 92% would be defined as = 0.
If saturation O2 < 92 %, then it would be definded as Unsuccessful = 1 Continuous monitoring and recording of implementation initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
measure: Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Successful maintenance of saturation O2 in Hemoglobulin within normal range would be defined as = 0.
If saturation O2 < 92 %, then it would be definded as Unsuccessful = 1
Continuous monitoring and recording of implementation initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation
measure: Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, FiO2: 60%, 15L/min
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Successful maintenance of saturation O2 in Hemoglobulin > 92% would be defined as = 0. If saturation O2 < 92 %, then would be defined as Unsuccessful = 1 .
Continuous monitoring and recording of implementation Venturi mask FiO2 : 60%, 15L/min.
measure: Mobilization of accessory respiratory muscles with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilization and use of accessory respiratory muscles
measure: Mobilization of accessory respiratory muscles with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilzation and use of accessory respiratory muscles
measure: Mobilization of accessory respiratory muscles with Venturi mask, FiO2: 60%, 15L/min To record any use of accessory respiratory muscles with Venturi mask , FiO2: 60%, 15L/min
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: Success would be defined as = 0 when there would be no mobilization of accessory respiratory muscles. Failure would be defined as = 1 when there would be recorded any mobilzation and use of accessory respiratory muscles
measure: Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale
measure: Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale
measure: Comfort and tolerance of treatment with Visual Analogue Scale with Venturi mask , FiO2: 60%, 15L/min
time frame: Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours)
description: To monitor and record comfort of patient with the diagnostic tool of Visual Analogue Scale
measure: Length of Stay in the ICU
time frame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge
description: There will be recorded the total length of stay in the ICU since admission post surgery
measure: Length of Stay in the Hospital
time frame: Post ICU admission period up to actual hospital discharge
description: There will be recorded the total length of stay in the hospital since ICU admission
measure: Number of participants with death in the cardiothoracic ICU post extubation
time frame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge
description: There will be recorded the number of participants that will pass away post extubation in the ICU
measure: Number of participants with death in the hospital post ICU discharge
time frame: Post ICU discharge period up to actual hospital discharge
description: There will be recorded the number of participants that will pass away post extubation in the hospital , after the ICU discharge
measure: Number of participants with Atrial Fibrillation in the ICU post extubation
time frame: Post ICU admission period up to 48 hours or actual ICU discharge
description: There will be recorded the number of participants that will present Atrial Fibrillation post extubation in the ICU
measure: Number of participants with any Adverse Events in the ICU
time frame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge
description: There will be recorded the number of participants that will present any Adverse Events (respiratory , non-respiratory) post extubation in the ICU
measure: Number of participants with any Adverse Events in the Hospital
time frame: Up to 1 month, or until actual hospital discharge
description: There will be recorded the number of participants that will present any Adverse Events (respiratory, non-respiratory) post extubation in the ICU, until hospital discharge.
measure: Percentage of participants presenting unsuccessful (failed) implementation of NHFO treatment
time frame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge
description: There will be recorded the number of participants that will present failure to comply with the treatment due to failing to maintain their respiratory parameters within normal range, or due to presenting intolerance and discomfort to the implementation of NHFO treatment
measure: Number of participants with re-intubation in the ICU
time frame: Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge
description: There will be recorded the number of participants that will be re-intubated due to deterioration of their respiratory parameters.
arm group label: Study Group 1
arm group type: Active Comparator
description: The intervention consists of the implementation of Nasal Cannula High Flow Oxygenation as an oxygen treatment at Study Group 1, whereas oxygen supply was provided via Venturi mask at the standard oxygen patients' treatment.
The first Study Group will include patients on Nasal Cannula High Flow Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.
arm group label: Study Group 2
arm group type: Active Comparator
description: The intervention consists of the implementation of Nasal Cannula High Flow Oxygenation as an oxygen treatment at Study Group 2, whereas oxygen supply was provided via Venturi mask at the standard oxygen patients' treatment.
The second Study Group will include patients on Nasal Cannula High Flow Oxygenation with initial settings of FiO2=60% and gas flow=40L/min.
arm group label: Control group
arm group type: No Intervention
description: In the third group (control group) all patients will receive oxygen treatment according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 15L/min.
In this group all patients will receive the usual standard of care, with no other interventions included
intervention type: Device
intervention name: Nasal Cannula High Flow Oxygen
description: Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)
arm group label: Study Group 1
arm group label: Study Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Spiros Zakynthinos, Professor
role: Study Chair
affiliation: National and Kapodistrian University of Athens
last name: Spiridon Mentzelopoulos, AssProfessor
role: Study Director
affiliation: National and Kapodistrian University of Athens
facility: 
country: Greece
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responsible party type: Principal Investigator
investigator affiliation: National and Kapodistrian University of Athens
investigator full name: Stavros Theologou
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
sharing ipd: No
provided document: 