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.

Study Overview
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Brief Summary
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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
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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: Oxygen Difference pre/post-hood (SaO2 difference, %) Intubation/MV status (Intubated) Survival/Mortality (Expired) 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.

Official Title
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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.

Conditions
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COVID -19, Respiratory Failure, Hypoxia

Intervention / Treatment
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* Device: Oxygen Hood


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Patients on oxygen hoods who have fail conventional high-flow oxygen delivery systems. | Device: Oxygen Hood<br>* High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.<br>* Other names: Oxygen Helmets;|
| Control<br>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?
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Primary Outcome Measures

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