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Completed

NCT Number: NCT04407260

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.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen Hood

Device

High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.

Other names: Oxygen Helmets

Primary outcomes

  1. Oxygen saturation

    Time frame: 3/6/2020 - 5/1/2020

    Continuous pulse oximetry monitoring

  2. In-hospital Intubation/Mechanical Ventilation Status

    Time frame: 3/6/2020 - 5/1/2020

    Intubation/mechanical Ventilation at any point during hospitalization.

  3. In-hospital Mortality

    Time frame: 3/6/2020 - 5/1/2020

    In-hospital Mortality status

  4. Length of Hospitalization

    Time frame: 3/6/2020 - 5/1/2020

    Duration of hospitalization

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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