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The Use of Oxygen Hoods as Compared to 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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407260
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
David Dayya, Northwell Health

Brief Summary:
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.

Condition or disease Intervention/treatment
COVID -19 Respiratory Failure Hypoxia Device: Oxygen Hood

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Oxygen Hoods as Compared to 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.
Actual Study Start Date : March 6, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Intervention
Patients on oxygen hoods who have fail conventional high-flow oxygen delivery systems.
Device: Oxygen Hood
High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.
Other Name: Oxygen Helmets

Control
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.



Primary Outcome Measures :
  1. Oxygen saturation [ Time Frame: 3/6/2020 - 5/1/2020 ]
    Continuous pulse oximetry monitoring

  2. In-hospital Intubation/Mechanical Ventilation Status [ Time Frame: 3/6/2020 - 5/1/2020 ]
    Intubation/mechanical Ventilation at any point during hospitalization.

  3. In-hospital Mortality [ Time Frame: 3/6/2020 - 5/1/2020 ]
    In-hospital Mortality status

  4. Length of Hospitalization [ Time Frame: 3/6/2020 - 5/1/2020 ]
    Duration of hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All COVID-19 patients presenting to the hospital prior to the availability of oxygen hoods were reviewed for eligibility and assignment to the control cohort.

All COVID-19 patients presenting to the hospital after the availability of oxygen hoods were reviewed for eligibility and assignment to the intervention cohort if they were failing on conventional high-flow oxygen delivery systems.

Criteria

Inclusion Criteria

  • Hospital census is reviewed for ALL patients seen in the Emergency Department admitted with COVID -19 diagnosis and experiencing hypoxia requiring supplemental high-flow oxygen delivery or who have required mechanical ventilation.
  • Consent (native language services provided).
  • No limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy status, DNR/DNI status.

Exclusion Criteria

  • SaO2 > 90% on conventional high-flow O2-delivery system.
  • Confinement anxiety post-oxygen hood placement with request for removal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407260


Locations
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United States, New York
Phelps Hospital
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: David Dayya, DO, PhD, MPH Phelps Hospital - Northwell Health
Principal Investigator: Owen J O'Neill, MD, MPH, FUHM Phelps Hospital - Northwell Health
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Responsible Party: David Dayya, Attending Physician, Northwell Health
ClinicalTrials.gov Identifier: NCT04407260    
Other Study ID Numbers: HoodStudy701
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If other researchers are investigating similar research question will consider sharing IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory