Use of Oxygen Hoods in Patients Failing on Conventional High-flow Oxygen Delivery Systems, Effects on Oxygenation, Mechanical Ventilation and Mortality Rates in Hypoxic COVID-19 Patients. Prospective Cohort Study.
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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:
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Oxygen Difference pre/post-hood (SaO2 difference, %)
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Intubation/MV status (Intubated)
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Survival/Mortality (Expired)
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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 Design
Arms and Interventions
| Arm | 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:
|
| 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. |
Outcome Measures
Primary Outcome Measures
- 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.
- In-hospital Mortality [3/6/2020 - 5/1/2020]
In-hospital Mortality status
- Length of Hospitalization [3/6/2020 - 5/1/2020]
Duration of hospitalization
Eligibility Criteria
Criteria
Inclusion Criteria
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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.
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Consent (native language services provided).
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No limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy status, DNR/DNI status.
Exclusion Criteria
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SaO2 > 90% on conventional high-flow O2-delivery system.
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Confinement anxiety post-oxygen hood placement with request for removal.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phelps Hospital | Sleepy Hollow | New York | United States | 10591 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- HoodStudy701