Status:
COMPLETED
Pilot Study to Evaluate the Revoxa™ System in Hypoxic Patients
Lead Sponsor:
Dr. David Maslove
Collaborating Sponsors:
Ironstone Professional Development
Conditions:
Hypoxemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with COVID-19 may suffer from profound hypoxia, requiring the use of supplemental oxygen at high concentrations and flow rates. Non-invasive oxygen delivery systems such as high-flow nasal ca...
Detailed Description
This study aims to investigate a two-phase rebreather system (Revoxa Oxygen Rebreather device) among hospitalized patients requiring oxygen therapy. This system can deliver a high fraction of inspired...
Eligibility Criteria
Inclusion
- Group A - Healthy adults (≥ 18 years of age) with SpO2 ≥ 96% without oxygen supplementation
- Group B - non-severe hypoxemia requiring supplemental oxygen as defined by:
- SpO2 \> 96% with oxygen face mask or nasal cannula with low flow oxygen \<5LPM
- Adults (≥ 18 years of age)
- Group C - Hypoxemia requiring supplemental oxygen as defined by:
- Oxygen saturation (SpO2) ≤ 92% on room air as measured by pulse oximetry; or
- SpO2 \< 94% with oxygen face mask or nasal cannula with low flow oxygen \<5LPM
- Adults (≥ 18 years of age)
Exclusion
- Acute / unstable cardiovascular condition
- Pregnancy
- Imminent need for intubation or noninvasive ventilation
- Glasgow coma scale \<14
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04699942
Start Date
February 1 2021
End Date
May 1 2021
Last Update
January 17 2024
Active Locations (1)
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1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7