COVID -19, Hypoxia, Respiratory Failure
Conditions
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.
Interventions
DEVICEOxygen Hood
High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.
Sponsors
Northwell Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed