<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/NCT04408222</url>
  </required_header>
  <id_info>
    <org_study_id>AAAT0134</org_study_id>
    <nct_id>NCT04408222</nct_id>
  </id_info>
  <brief_title>Awake Proning in COVID-19 Patients With Hypoxemic Respiratory Failure</brief_title>
  <official_title>Awake Proning in Patients With COVID-19-Induced Acute Hypoxemic Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia 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 purpose of this study is to retrospectively review clinical data to determine whether&#xD;
      awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe&#xD;
      hypoxemic respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill patients with coronavirus disease 2019 (COVID-19) severely strained intensive&#xD;
      care resources in New York in April 2020. The prone position improves oxygenation in&#xD;
      intubated patients with acute respiratory distress syndrome. The investigators wanted to&#xD;
      study whether the prone position is associated with improved oxygenation and decreased risk&#xD;
      for intubation in spontaneously breathing patients with severe COVID-19 hypoxemic respiratory&#xD;
      failure. Awake prone positioning was implemented based on the health care provider decision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2020</start_date>
  <completion_date type="Actual">March 6, 2022</completion_date>
  <primary_completion_date type="Actual">April 16, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in SpO2</measure>
    <time_frame>Before proning and 1 hour after initiation of the prone position</time_frame>
    <description>SpO2 was measured by peripheral pulse oximetry.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Risk Difference in Intubation Rates</measure>
    <time_frame>Duration of hospitalization or up to 1 month from admission</time_frame>
    <description>The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. &lt;95% 1 hour after initiation of the prone position was assessed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Oxygen Deficiency</condition>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>Awake Proning</arm_group_label>
    <description>COVID-19 patients with hypoxemic respiratory failure with awake prone positioning, as tolerated, up to 24 hours daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Awake proning</intervention_name>
    <description>Prone positioning of awake, as tolerated, for up to 24 hours daily.</description>
    <arm_group_label>Awake Proning</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with laboratory-confirmed COVID-19 infection who were admitted to the&#xD;
        step-down unit at the Columbia University Irving Medical Center in New York between April 6&#xD;
        and 14, 2020 were included. A confirmed case of COVID-19 was defined by a positive result&#xD;
        on a reverse transcriptase-polymerase chain reaction (RT-PCR) assay of a specimen collected&#xD;
        on a nasopharyngeal swab. Only laboratory-confirmed cases were included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients admitted to the Columbia University step-down unit from April 6,&#xD;
             2020.&#xD;
&#xD;
          -  Laboratory confirmed COVID-19 infection with severe hypoxemic respiratory failure&#xD;
             defined as respiratory rate ≥30 breaths/min and oxyhemoglobin saturation (SpO2) ≤93%&#xD;
             while receiving supplemental oxygen 6 L/min via nasal cannula and 15 L/min via&#xD;
             non-rebreather facemask.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Altered mental status with inability to turn in bed without assistance&#xD;
&#xD;
          -  Extreme respiratory distress requiring immediate intubation, or oxygen requirements&#xD;
             less than specified in the inclusion criteria.&#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>Sanja Jelic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.</citation>
    <PMID>23688302</PMID>
  </reference>
  <reference>
    <citation>Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.</citation>
    <PMID>24134414</PMID>
  </reference>
  <reference>
    <citation>Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.</citation>
    <PMID>32189136</PMID>
  </reference>
  <reference>
    <citation>Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y. No abstract available.</citation>
    <PMID>32204726</PMID>
  </reference>
  <reference>
    <citation>Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.</citation>
    <PMID>32000806</PMID>
  </reference>
  <reference>
    <citation>https://www1.nyc.gov/site/doh/Covid/Covid-19-data.page; Accessed April 17, 2020.</citation>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Sanja Jelic</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Awake Proning</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared owing to privacy protection.</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/NCT04408222
org study id: AAAT0134
nct id: NCT04408222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to retrospectively review clinical data to determine whether
      awake proning improves oxygenation in spontaneously breathing patients with COVID-19 severe
      hypoxemic respiratory failure.
Critically ill patients with coronavirus disease 2019 (COVID-19) severely strained intensive
      care resources in New York in April 2020. The prone position improves oxygenation in
      intubated patients with acute respiratory distress syndrome. The investigators wanted to
      study whether the prone position is associated with improved oxygenation and decreased risk
      for intubation in spontaneously breathing patients with severe COVID-19 hypoxemic respiratory
      failure. Awake prone positioning was implemented based on the health care provider decision.
observational model: Cohort
time perspective: Retrospective
measure: Change in SpO2
time frame: Before proning and 1 hour after initiation of the prone position
description: SpO2 was measured by peripheral pulse oximetry.
measure: Mean Risk Difference in Intubation Rates
time frame: Duration of hospitalization or up to 1 month from admission
description: The mean risk difference in intubation rates for patients with SpO2 ≥95% vs. <95% 1 hour after initiation of the prone position was assessed.
arm group label: Awake Proning
description: COVID-19 patients with hypoxemic respiratory failure with awake prone positioning, as tolerated, up to 24 hours daily.
intervention type: Other
intervention name: Awake proning
description: Prone positioning of awake, as tolerated, for up to 24 hours daily.
arm group label: Awake Proning
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sanja Jelic, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
citation: Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
PMID: 23688302
citation: Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.
PMID: 24134414
citation: Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available.
PMID: 32189136
citation: Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y. No abstract available.
PMID: 32204726
citation: Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
PMID: 32000806
citation: https://www1.nyc.gov/site/doh/Covid/Covid-19-data.page; Accessed April 17, 2020.
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Sanja Jelic
investigator title: Associate Professor of Medicine
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Respiratory Insufficiency
mesh term: Hypoxia
sharing ipd: No
ipd description: Individual participant data will not be shared owing to privacy protection.