<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/NCT04407260</url>
  </required_header>
  <id_info>
    <org_study_id>HoodStudy701</org_study_id>
    <nct_id>NCT04407260</nct_id>
  </id_info>
  <brief_title>Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, Effects on Oxygenation in Hypoxic COVID-19 Patients. Prospective Cohort Study.</brief_title>
  <official_title>The Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen&#xD;
      delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates&#xD;
      in hypoxic patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine whether Oxygen hoods improve O2-saturation (SaO2), and how they effect length of&#xD;
      hospitalization, and in-hospital mechanical ventilation and mortality rates in Covid-19&#xD;
      patients when compared to conventional high-flow oxygen delivery systems. Oxy-hemoglobin&#xD;
      saturation is continuously measured by pulse-oximetry including immediately before and after&#xD;
      oxygen hood placement, and will be measured in controls.&#xD;
&#xD;
      Comparison/Control Group The control cohort includes COVID-19 patients presenting for&#xD;
      treatment prior to 4/3/20 when hyperbaric oxygen hoods were not available. Patients&#xD;
      maintained on, or those failing on conventional O2- delivery systems and subsequently&#xD;
      receiving mechanical ventilation will be studied.&#xD;
&#xD;
      All patients included must have tested positive using PCR swabs and/or been diagnosed based&#xD;
      on clinical/laboratory standard diagnostic criteria. Medical management will include evolving&#xD;
      treatment regimens and other standard medical treatments widely used at time of study in all&#xD;
      hypoxic COVID-19 patients.&#xD;
&#xD;
      Prognostic/confounding covariates are to be collected through Electronic Medical Record (EMR)&#xD;
      chart review and compared between intervention and control cohorts. including: Age, Body Mass&#xD;
      Index (BMI), Gender, Chronic Lung disease - COPD, Asthma (CLD), cardiovascular disease - CAD,&#xD;
      CHF, Chronic Dysrhythmia (CVD), chronic kidney disease (CKD), Immunosuppression - History of&#xD;
      Cancer, Immunosuppressive medication, HIV (Immunosuppression), Diabetes Mellitus (DM), and&#xD;
      pertinent lab markers.&#xD;
&#xD;
      Routine follow-up evaluation is maintained until final in-hospital outcomes are known&#xD;
      including:&#xD;
&#xD;
        1. Oxygen Difference pre/post-hood (SaO2 difference, %)&#xD;
&#xD;
        2. Intubation/MV status (Intubated)&#xD;
&#xD;
        3. Survival/Mortality (Expired)&#xD;
&#xD;
        4. Hospital Length of Stay (LOS, days)&#xD;
&#xD;
      Randomization/Blinding Randomization is not possible as it is unethical to deny a hypoxic&#xD;
      patient an alternative approved means of oxygenation for patients failing on conventional&#xD;
      oxygen delivery systems. No blinding of participants or investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>3/6/2020 - 5/1/2020</time_frame>
    <description>Continuous pulse oximetry monitoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-hospital Intubation/Mechanical Ventilation Status</measure>
    <time_frame>3/6/2020 - 5/1/2020</time_frame>
    <description>Intubation/mechanical Ventilation at any point during hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-hospital Mortality</measure>
    <time_frame>3/6/2020 - 5/1/2020</time_frame>
    <description>In-hospital Mortality status</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of Hospitalization</measure>
    <time_frame>3/6/2020 - 5/1/2020</time_frame>
    <description>Duration of hospitalization</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">136</enrollment>
  <condition>COVID -19</condition>
  <condition>Respiratory Failure</condition>
  <condition>Hypoxia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <description>Patients on oxygen hoods who have fail conventional high-flow oxygen delivery systems.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Patients maintained on conventional high-flow oxygen delivery systems (such as non-rebreather masks, high-flow nasal cannula, BiPAP, CPAP) or who have failed on these conventional symptoms and were subsequently mechanically ventilated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxygen Hood</intervention_name>
    <description>High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Oxygen Helmets</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All COVID-19 patients presenting to the hospital prior to the availability of oxygen hoods&#xD;
        were reviewed for eligibility and assignment to the control cohort.&#xD;
&#xD;
        All COVID-19 patients presenting to the hospital after the availability of oxygen hoods&#xD;
        were reviewed for eligibility and assignment to the intervention cohort if they were&#xD;
        failing on conventional high-flow oxygen delivery systems.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Hospital census is reviewed for ALL patients seen in the Emergency Department admitted&#xD;
             with COVID -19 diagnosis and experiencing hypoxia requiring supplemental high-flow&#xD;
             oxygen delivery or who have required mechanical ventilation.&#xD;
&#xD;
          -  Consent (native language services provided).&#xD;
&#xD;
          -  No limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy&#xD;
             status, DNR/DNI status.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  SaO2 &gt; 90% on conventional high-flow O2-delivery system.&#xD;
&#xD;
          -  Confinement anxiety post-oxygen hood placement with request for removal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Dayya, DO, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Phelps Hospital - Northwell Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Owen J O'Neill, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Phelps Hospital - Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phelps Hospital</name>
      <address>
        <city>Sleepy Hollow</city>
        <state>New York</state>
        <zip>10591</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Organization WH. Rolling updates on Coronavirus disease (COVID - 19) - Coronavirus disease (COVID-19) Situation Report.: World Health Organization, 2020.</citation>
  </reference>
  <reference>
    <citation>Control CfD. Recommended Preparedness and Response Activities in Healthcare. Supplement C: Preparedness and Response In Healthcare Facilities. Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS) Version 2/3.</citation>
  </reference>
  <reference>
    <citation>Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098.</citation>
    <PMID>32320003</PMID>
  </reference>
  <reference>
    <citation>Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020 Dec 17;383(25):2451-2460. doi: 10.1056/NEJMcp2009575. Epub 2020 May 15. No abstract available.</citation>
    <PMID>32412710</PMID>
  </reference>
  <reference>
    <citation>Health. NDo. Amid Ongoing COVID-19 Pandemic, Governor Cuomo Announces State Department of Health Has Approved New Protocol to Allow BiPAP Machines to be Converted Into Ventilators.</citation>
  </reference>
  <reference>
    <citation>Wang L, He W, Yu X, Hu D, Bao M, Liu H, Zhou J, Jiang H. Coronavirus disease 2019 in elderly patients: Characteristics and prognostic factors based on 4-week follow-up. J Infect. 2020 Jun;80(6):639-645. doi: 10.1016/j.jinf.2020.03.019. Epub 2020 Mar 30.</citation>
    <PMID>32240670</PMID>
  </reference>
  <reference>
    <citation>Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.</citation>
    <PMID>27179847</PMID>
  </reference>
  <reference>
    <citation>Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124.</citation>
    <PMID>29595563</PMID>
  </reference>
  <reference>
    <citation>K M. Oxygen Administration: What Is the Best Choice? Respiratory Therapy 2015.</citation>
  </reference>
  <reference>
    <citation>Department of Health and Human Services - Food and drug Administration - Conference of CDRH OoDEO. Device Evaluation and Approval., 2002.</citation>
  </reference>
  <reference>
    <citation>UN-TBftLDC. Local production could solve shortages of essential pandemic-fighting equipment., 2020.</citation>
  </reference>
  <reference>
    <citation>MEDICINE. ECFH. ECHM position on Hyperbaric Oxygen Therapy (HBOT) in multiplace hyperbaric chambers during coronavirus disease (COVID-19) outbreak.</citation>
  </reference>
  <reference>
    <citation>B L, A C, Z B, et al. COVID-19: Oxygen Escalation Therapy and Noninvasive Ventilation. EmDocs 2020. http://www.emdocs.net/covid-19-oxygen-escalation-therapy-and-noninvasive-ventilation/ (accessed April 15, 2020).</citation>
  </reference>
  <reference>
    <citation>Prevention CfDCa. Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19). 2020.</citation>
  </reference>
  <reference>
    <citation>Ashraf-Kashani N, R K. High-flow nasal oxygen therapy. BJA Education;17(2):57-62.</citation>
  </reference>
  <reference>
    <citation>Rengasamy S, Shaffer R, Williams B, Smit S. A comparison of facemask and respirator filtration test methods. J Occup Environ Hyg. 2017 Feb;14(2):92-103. doi: 10.1080/15459624.2016.1225157. Erratum In: J Occup Environ Hyg. 2017 Apr;14 (4):D64.</citation>
    <PMID>27540979</PMID>
  </reference>
  <reference>
    <citation>Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.</citation>
    <PMID>32329799</PMID>
  </reference>
  <reference>
    <citation>IBM SPSS Statistics for Windows [program]. 25.0 version. Armonk, NY: IBM Corp., Released 2017.</citation>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>David Dayya</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <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>Undecided</sharing_ipd>
    <ipd_description>If other researchers are investigating similar research question will consider sharing IPD.</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/NCT04407260
org study id: HoodStudy701
nct id: NCT04407260
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
To determine whether the use of oxygen hoods as compared to conventional high-flow oxygen
      delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates
      in hypoxic patients with COVID-19.
To determine whether Oxygen hoods improve O2-saturation (SaO2), and how they effect length of
      hospitalization, and in-hospital mechanical ventilation and mortality rates in Covid-19
      patients when compared to conventional high-flow oxygen delivery systems. Oxy-hemoglobin
      saturation is continuously measured by pulse-oximetry including immediately before and after
      oxygen hood placement, and will be measured in controls.

      Comparison/Control Group The control cohort includes COVID-19 patients presenting for
      treatment prior to 4/3/20 when hyperbaric oxygen hoods were not available. Patients
      maintained on, or those failing on conventional O2- delivery systems and subsequently
      receiving mechanical ventilation will be studied.

      All patients included must have tested positive using PCR swabs and/or been diagnosed based
      on clinical/laboratory standard diagnostic criteria. Medical management will include evolving
      treatment regimens and other standard medical treatments widely used at time of study in all
      hypoxic COVID-19 patients.

      Prognostic/confounding covariates are to be collected through Electronic Medical Record (EMR)
      chart review and compared between intervention and control cohorts. including: Age, Body Mass
      Index (BMI), Gender, Chronic Lung disease - COPD, Asthma (CLD), cardiovascular disease - CAD,
      CHF, Chronic Dysrhythmia (CVD), chronic kidney disease (CKD), Immunosuppression - History of
      Cancer, Immunosuppressive medication, HIV (Immunosuppression), Diabetes Mellitus (DM), and
      pertinent lab markers.

      Routine follow-up evaluation is maintained until final in-hospital outcomes are known
      including:

        1. Oxygen Difference pre/post-hood (SaO2 difference, %)

        2. Intubation/MV status (Intubated)

        3. Survival/Mortality (Expired)

        4. Hospital Length of Stay (LOS, days)

      Randomization/Blinding Randomization is not possible as it is unethical to deny a hypoxic
      patient an alternative approved means of oxygenation for patients failing on conventional
      oxygen delivery systems. No blinding of participants or investigators.
observational model: Cohort
time perspective: Prospective
measure: Oxygen saturation
time frame: 3/6/2020 - 5/1/2020
description: Continuous pulse oximetry monitoring
measure: In-hospital Intubation/Mechanical Ventilation Status
time frame: 3/6/2020 - 5/1/2020
description: Intubation/mechanical Ventilation at any point during hospitalization.
measure: In-hospital Mortality
time frame: 3/6/2020 - 5/1/2020
description: In-hospital Mortality status
measure: Length of Hospitalization
time frame: 3/6/2020 - 5/1/2020
description: Duration of hospitalization
arm group label: Intervention
description: Patients on oxygen hoods who have fail conventional high-flow oxygen delivery systems.
arm group label: Control
description: Patients maintained on conventional high-flow oxygen delivery systems (such as non-rebreather masks, high-flow nasal cannula, BiPAP, CPAP) or who have failed on these conventional symptoms and were subsequently mechanically ventilated.
intervention type: Device
intervention name: Oxygen Hood
description: High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.
arm group label: Intervention
other name: Oxygen Helmets
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David Dayya, DO, PhD, MPH
role: Principal Investigator
affiliation: Phelps Hospital - Northwell Health
last name: Owen J O'Neill, MD, MPH
role: Principal Investigator
affiliation: Phelps Hospital - Northwell Health
facility: 
country: United States
citation: Organization WH. Rolling updates on Coronavirus disease (COVID - 19) - Coronavirus disease (COVID-19) Situation Report.: World Health Organization, 2020.
citation: Control CfD. Recommended Preparedness and Response Activities in Healthcare. Supplement C: Preparedness and Response In Healthcare Facilities. Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS) Version 2/3.
citation: Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098.
PMID: 32320003
citation: Berlin DA, Gulick RM, Martinez FJ. Severe Covid-19. N Engl J Med. 2020 Dec 17;383(25):2451-2460. doi: 10.1056/NEJMcp2009575. Epub 2020 May 15. No abstract available.
PMID: 32412710
citation: Health. NDo. Amid Ongoing COVID-19 Pandemic, Governor Cuomo Announces State Department of Health Has Approved New Protocol to Allow BiPAP Machines to be Converted Into Ventilators.
citation: Wang L, He W, Yu X, Hu D, Bao M, Liu H, Zhou J, Jiang H. Coronavirus disease 2019 in elderly patients: Characteristics and prognostic factors based on 4-week follow-up. J Infect. 2020 Jun;80(6):639-645. doi: 10.1016/j.jinf.2020.03.019. Epub 2020 Mar 30.
PMID: 32240670
citation: Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2016 Jun 14;315(22):2435-41. doi: 10.1001/jama.2016.6338.
PMID: 27179847
citation: Patel BK, Wolfe KS, MacKenzie EL, Salem D, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Macleod J, Pohlman AS, Hall JB, Kress JP. One-Year Outcomes in Patients With Acute Respiratory Distress Syndrome Enrolled in a Randomized Clinical Trial of Helmet Versus Facemask Noninvasive Ventilation. Crit Care Med. 2018 Jul;46(7):1078-1084. doi: 10.1097/CCM.0000000000003124.
PMID: 29595563
citation: K M. Oxygen Administration: What Is the Best Choice? Respiratory Therapy 2015.
citation: Department of Health and Human Services - Food and drug Administration - Conference of CDRH OoDEO. Device Evaluation and Approval., 2002.
citation: UN-TBftLDC. Local production could solve shortages of essential pandemic-fighting equipment., 2020.
citation: MEDICINE. ECFH. ECHM position on Hyperbaric Oxygen Therapy (HBOT) in multiplace hyperbaric chambers during coronavirus disease (COVID-19) outbreak.
citation: B L, A C, Z B, et al. COVID-19: Oxygen Escalation Therapy and Noninvasive Ventilation. EmDocs 2020. http://www.emdocs.net/covid-19-oxygen-escalation-therapy-and-noninvasive-ventilation/ (accessed April 15, 2020).
citation: Prevention CfDCa. Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19). 2020.
citation: Ashraf-Kashani N, R K. High-flow nasal oxygen therapy. BJA Education;17(2):57-62.
citation: Rengasamy S, Shaffer R, Williams B, Smit S. A comparison of facemask and respirator filtration test methods. J Occup Environ Hyg. 2017 Feb;14(2):92-103. doi: 10.1080/15459624.2016.1225157. Erratum In: J Occup Environ Hyg. 2017 Apr;14 (4):D64.
PMID: 27540979
citation: Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.
PMID: 32329799
citation: IBM SPSS Statistics for Windows [program]. 25.0 version. Armonk, NY: IBM Corp., Released 2017.
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: David Dayya
investigator title: Attending Physician
mesh term: Respiratory Insufficiency
mesh term: Hypoxia
sharing ipd: Undecided
ipd description: If other researchers are investigating similar research question will consider sharing IPD.