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.

Completed

• Conditions: COVID -19; Hypoxia; Respiratory Failure
• Interventions: Device: Oxygen Hood

• Registration Number: NCT04407260
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-03-06
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Oxygen Hood	Patients on oxygen hoods who have fail conventional high-flow oxygen delivery systems.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Phelps Hospital; 🇺🇸 Sleepy Hollow, New York, United States