The Use of Oxygen Hoods as Compared to 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.
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|ClinicalTrials.gov Identifier: NCT04407260|
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment|
|COVID -19 Respiratory Failure Hypoxia||Device: Oxygen Hood|
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.
|Study Type :||Observational|
|Actual Enrollment :||136 participants|
|Official Title:||The Use of Oxygen Hoods as Compared to 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.|
|Actual Study Start Date :||March 6, 2020|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
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 Name: Oxygen Helmets
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.
- Oxygen saturation [ Time Frame: 3/6/2020 - 5/1/2020 ]Continuous pulse oximetry monitoring
- In-hospital Intubation/Mechanical Ventilation Status [ Time Frame: 3/6/2020 - 5/1/2020 ]Intubation/mechanical Ventilation at any point during hospitalization.
- In-hospital Mortality [ Time Frame: 3/6/2020 - 5/1/2020 ]In-hospital Mortality status
- Length of Hospitalization [ Time Frame: 3/6/2020 - 5/1/2020 ]Duration of hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407260
|United States, New York|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||David Dayya, DO, PhD, MPH||Phelps Hospital - Northwell Health|
|Principal Investigator:||Owen J O'Neill, MD, MPH, FUHM||Phelps Hospital - Northwell Health|