The Use of Oxygen Hoods as Compared to Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Intubation and Mortality Rates in Hypoxic Patients With COVID-19.

Overview

To determine whether Oxygen hoods improve O2-saturation (SaO2), length of hospitalization, in-hospital intubation, and mortality rates in Covid-19 patients when compared to conventional high-flow oxygen delivery systems.

Full Title of Study: “The Use of Oxygen Hoods as Compared to Conventional High-flow Oxygen Delivery Systems, the Effects on Oxygenation, Intubation and Mortality Rates, and Length of Hospitalization in Hypoxic Patients With COVID-19. A Prospective Controlled Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 1, 2020

Detailed Description

To determine whether Oxygen hoods improve O2-saturation (SaO2), and how they effect length of hospitalization, in-hospital intubation, 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 on 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.

Interventions

  • Device: Oxygen Hood
    • High-Flow Oxygen Hood with neck dam and intake and exhaust tubing with Bacterial/Viral HEPA filter and optional PEEP attachment.

Arms, Groups and Cohorts

  • Intervention
    • Patients on Oxygen Hoods who have failed conventional high-flow oxygen delivery systems.
  • Control
    • Conventional High-Flow Oxygen Delivery Systems (such as non-rebreather masks, high-flow nasal cannula, BiPAP, CPAP)

Clinical Trial Outcome Measures

Primary Measures

  • Oxygen saturation
    • Time Frame: 3/6/2020 – 5/1/2020
    • Continuous pulse oximetry monitoring
  • In-hospital Intubation/Mechanical Ventilation
    • Time Frame: 3/6/2020 – 5/1/2020
    • Intubation/mechanical Ventilation at any point during hospitalization.
  • In-hospital Mortality
    • Time Frame: 3/6/2020 – 5/1/2020
    • In-hospital Mortality status
  • Length of Hospitalization
    • Time Frame: 3/6/2020 – 5/1/2020
    • Duration of hospitalization

Participating in This Clinical Trial

Inclusion Criteria

  • Hospital census is reviewed for ALL patients seen in the ED and/or admitted with COVID -19 diagnosis with hypoxia requiring supplemental high-flow oxygen delivery or 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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwell Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Dayya, Attending Physician – Northwell Health
  • Overall Official(s)
    • David Dayya, DO, PhD, MPH, Principal Investigator, Phelps Hospital – Northwell Health
    • Owen J O’Neill, MD, MPH, FUHM, Principal Investigator, Phelps Hospital – Northwell Health

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