xml: <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/NCT05990101</url>
    </required_header>
    <id_info>
      <org_study_id>2023/6-1517-981</org_study_id>
      <nct_id>NCT05990101</nct_id>
    </id_info>
    <brief_title>HYPoxaEmic Respiratory Failure and Awake Prone Ventilation</brief_title>
    <acronym>Hyper-AP</acronym>
    <official_title>HYPoxaEmic Respiratory Failure and Awake Prone Ventilation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vilnius University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Vilnius University Hospital Santaros Klinikos</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Vilnius University</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>
        The goal of this prospective multi-centre randomised controlled trial is to determine if&#xD;
        addition of awake prone positioning to standard oxygen, high flow oxygen therapy and&#xD;
        non-invasive ventilation may reduce the rates of endotracheal intubation and mechanical&#xD;
        ventilation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Effectiveness of prone position in mechanically ventilated patients was investigated&#xD;
        extensively. During the Covid-19 pandemic a sudden increase in cases of acute respiratory&#xD;
        failure, resulted in renewed interest and numerous studies on applying this concept in&#xD;
        spontaneously breathing patients and using this in conjunction with less invasive respiratory&#xD;
        support. However, evidence form the Covid-19 trials may not be directly extrapolated to other&#xD;
        acute respiratory distress causes (for example bacterial pneumonia) as pathology of lung&#xD;
        injury is distinctly different. Even though first reports of awake prone positioning were&#xD;
        published nearly 30 years ago, but to date there are no prospective randomised trials in&#xD;
        adult population treated for acute lung injury unrelated to Covid-19. Existing publications&#xD;
        range from case reports (lung transplantation and drowning cases) to small feasibility trials&#xD;
        involving 15-20 patients and also neonatal and paediatric populations. Considering that&#xD;
        patients with acute lung injury constitute a significant proportion of routine intensive care&#xD;
        unit population, results of this study would be highly relevant for the daily practice in&#xD;
        intensive care medicine.We are aiming to conduct a prospective multi-centre randomised&#xD;
        controlled trial comparing standard care alone with awake prone positioning and standard care&#xD;
        in spontaneously breathing patients admitted to Intensive or Intermediate Care Units for&#xD;
        acute non-Covid-19 hypoxemic respiratory failure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 12, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</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>Participants will be allocated to the awake prone or standard care groups on a 1:1 ratio.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>By the nature of the awake prone intervention, it will not be possible to blind clinicians; however, interventions will be blinded to data analysts and outcome assessors.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of endotracheal intubation</measure>
      <time_frame>Within 30 days of randomisation</time_frame>
      <description>Incidence of endotracheal intubation in both groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>Within 1 year of randomisation</time_frame>
      <description>Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of mechanical ventilation</measure>
      <time_frame>Within 30 days of randomisation</time_frame>
      <description>Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of intensive care unit and hospital stay</measure>
      <time_frame>Within 30 days of randomisation</time_frame>
      <description>Total cumulative number of days spent in intensive care unit and hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One year mortality</measure>
      <time_frame>Within 1 year of randomisation</time_frame>
      <description>Incidence or death during one year of randomisation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health related quality of life</measure>
      <time_frame>Within 1 year of randomisation</time_frame>
      <description>Heath related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) one year of randomisation</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Tolerance of awake prone positioning</measure>
      <time_frame>Within 72 hours of randomisation</time_frame>
      <description>Proportion of patients in the intervention group completing at least 4 hours per day of awake prone positioning and number of awake prone hours per day</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">262</enrollment>
    <condition>Respiratory Failure</condition>
    <condition>Hypoxemia</condition>
    <arm_group>
      <arm_group_label>APP group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Awake prone position (APP) for 4 or more hours per day in addition to standard care for the first 72 hours from randomisation. After the initial period, use of APP is at discretion of the treating clinician. Awake prone can be discontinued earlier if patients meets pre-specified criteria of sustained improvement.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard care excluding APP</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Awake prone position (APP)</intervention_name>
      <description>Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.</description>
      <arm_group_label>APP group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients admitted to intensive care unit for acute hypoxemic respiratory&#xD;
               failure.&#xD;
  &#xD;
            -  Acute hypoxemic respiratory failure is defined by respiratory rate ≥25 breaths/min,&#xD;
               and partial pressure of oxygen in the arterial blood (PaO2)/fraction of inspired&#xD;
               oxygen (FiO2) ≤300 mm Hg or oxygen saturation (SpO2)/fraction of inspired oxygen&#xD;
               (FiO2) ratio &lt;235 while spontaneously breathing under standard oxygen with oxygen flow&#xD;
               rate of at least 10 L/min, high flow oxygen therapy or non-invasive ventilation. For&#xD;
               patients under standard oxygen, FiO2 is calculated according to the following formula:&#xD;
               FiO2=0.21 + 0.03 per litre of supplemental oxygen.&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  impaired consciousness - Glasgow coma score &lt;14;&#xD;
  &#xD;
            -  inability to cooperate or prone position intolerance;&#xD;
  &#xD;
            -  immediate indications for endotracheal intubation;&#xD;
  &#xD;
            -  patients with do-not-intubate order at time of inclusion;&#xD;
  &#xD;
            -  patients with contraindication to high flow oxygen therapy (HFOT) or non-invasive&#xD;
               ventilation (NIV);&#xD;
  &#xD;
            -  Partial pressure of carbon dioxide (PaCO2) above 50 mm Hg and quantitative measure of&#xD;
               the acidity (pH) &lt;7,3;&#xD;
  &#xD;
            -  vasopressor dose &gt;0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic&#xD;
               blood pressure &gt;90 mmHg;&#xD;
  &#xD;
            -  Covid-19 positive&#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>Ieva Jovaisiene, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vilnius University Hospital Santaros Klinikos</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mandeep K Phull, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Barking, Havering and Redbridge University Hospitals NHS Trust</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Tomas Jovaisa, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vilnius University Hospital Santaros Klinikos</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tomas Jovaisa, Prof</last_name>
      <phone>+37062697567</phone>
      <email>tomas.jovaisa@santa.lt</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital of Lithuanian University of Health Sciences Kaunas Clinics</name>
        <address>
          <city>Kaunas</city>
          <country>Lithuania</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Tomas Tamosuitis, Dr</last_name>
        <phone>+37068780950</phone>
        <email>Tomas.Tamosuitis@kaunoklinikos.lt</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Republican Vilnius University Hospital</name>
        <address>
          <city>Vilnius</city>
          <zip>04130</zip>
          <country>Lithuania</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Saulius Vosylius, Prof</last_name>
        <email>saulius.vosylius@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Vilnius University Hospital Santaros Klinikos</name>
        <address>
          <city>Vilnius</city>
          <country>Lithuania</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Barking, Havering and Redbridge University Hospitals NHS Trust</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Mandeep K Phull, Dr</last_name>
        <email>mandeep.phull@nhs.net</email>
      </contact>
    </location>
    <location_countries>
      <country>Lithuania</country>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Awake prone</keyword>
    <keyword>Respiratory failure</keyword>
    <keyword>ARDS</keyword>
    <keyword>Hypoxaemia</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990101
  org study id: 2023/6-1517-981
  nct id: NCT05990101
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective multi-centre randomised controlled trial is to determine if
        addition of awake prone positioning to standard oxygen, high flow oxygen therapy and
        non-invasive ventilation may reduce the rates of endotracheal intubation and mechanical
        ventilation.
  Effectiveness of prone position in mechanically ventilated patients was investigated
        extensively. During the Covid-19 pandemic a sudden increase in cases of acute respiratory
        failure, resulted in renewed interest and numerous studies on applying this concept in
        spontaneously breathing patients and using this in conjunction with less invasive respiratory
        support. However, evidence form the Covid-19 trials may not be directly extrapolated to other
        acute respiratory distress causes (for example bacterial pneumonia) as pathology of lung
        injury is distinctly different. Even though first reports of awake prone positioning were
        published nearly 30 years ago, but to date there are no prospective randomised trials in
        adult population treated for acute lung injury unrelated to Covid-19. Existing publications
        range from case reports (lung transplantation and drowning cases) to small feasibility trials
        involving 15-20 patients and also neonatal and paediatric populations. Considering that
        patients with acute lung injury constitute a significant proportion of routine intensive care
        unit population, results of this study would be highly relevant for the daily practice in
        intensive care medicine.We are aiming to conduct a prospective multi-centre randomised
        controlled trial comparing standard care alone with awake prone positioning and standard care
        in spontaneously breathing patients admitted to Intensive or Intermediate Care Units for
        acute non-Covid-19 hypoxemic respiratory failure.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be allocated to the awake prone or standard care groups on a 1:1 ratio.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: By the nature of the awake prone intervention, it will not be possible to blind clinicians; however, interventions will be blinded to data analysts and outcome assessors.
  measure: Rate of endotracheal intubation
  time frame: Within 30 days of randomisation
  description: Incidence of endotracheal intubation in both groups
  measure: Mortality
  time frame: Within 1 year of randomisation
  description: Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year
  measure: Duration of mechanical ventilation
  time frame: Within 30 days of randomisation
  description: Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit
  measure: Length of intensive care unit and hospital stay
  time frame: Within 30 days of randomisation
  description: Total cumulative number of days spent in intensive care unit and hospital
  measure: One year mortality
  time frame: Within 1 year of randomisation
  description: Incidence or death during one year of randomisation
  measure: Health related quality of life
  time frame: Within 1 year of randomisation
  description: Heath related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) one year of randomisation
  measure: Tolerance of awake prone positioning
  time frame: Within 72 hours of randomisation
  description: Proportion of patients in the intervention group completing at least 4 hours per day of awake prone positioning and number of awake prone hours per day
  arm group label: APP group
  arm group type: Experimental
  description: Awake prone position (APP) for 4 or more hours per day in addition to standard care for the first 72 hours from randomisation. After the initial period, use of APP is at discretion of the treating clinician. Awake prone can be discontinued earlier if patients meets pre-specified criteria of sustained improvement.
  arm group label: Control group
  arm group type: No Intervention
  description: Standard care excluding APP
  intervention type: Behavioral
  intervention name: Awake prone position (APP)
  description: Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.
  arm group label: APP group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ieva Jovaisiene, Dr
  role: Principal Investigator
  affiliation: Vilnius University Hospital Santaros Klinikos
  last name: Mandeep K Phull, Dr
  role: Principal Investigator
  affiliation: Barking, Havering and Redbridge University Hospitals NHS Trust
  last name: Tomas Jovaisa, Prof
  role: Principal Investigator
  affiliation: Vilnius University Hospital Santaros Klinikos
  last name: Tomas Jovaisa, Prof
  phone: +37062697567
  email: tomas.jovaisa@santa.lt
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  country: Lithuania
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency
  mesh term: Hypoxia
  sharing ipd: No