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.

November 29, 2022 updated by: David Dayya, Northwell Health

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Sleepy Hollow, New York, United States, 10591
        • Phelps Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: David Dayya, DO, PhD, MPH, Phelps Hospital - Northwell Health
  • Principal Investigator: Owen J O'Neill, MD, MPH, Phelps Hospital - Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HoodStudy701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If other researchers are investigating similar research question will consider sharing IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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