Status:
UNKNOWN
Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Climate Foundation
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will die of complications. In patients with COVID-19, invasive treatment such as mechanical ventilation (e.g. breathing w...
Eligibility Criteria
Inclusion
- Male or non-pregnant female patients
- Age ≥18 years
- Confirmed COVID-19 positive by RT-PCR or another validated method
- Diagnosed with pneumonia requiring 21%\<FIO2≤100% to maintain saturation by pulse oximetry (SpO2) ≥90%
- Able and willing to comply with study procedures and follow-up examinations contained within the written consent form
Exclusion
- Patient clinical status felt to be incompatible with HBOT, e.g. respiratory failure requiring mechanical ventilation
- Pregnancy, determined by a serum or urine test
- Hemodynamic instability requiring vasopressors
- Inability to maintain a sitting position during treatment
- Inability to effectively understand and communicate with the hyperbaric operator, or to give consent
- Inability to spontaneously equalize ears and refusal of myringotomies
- Contraindications to HBOT (e.g. pneumothorax)
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04500626
Start Date
April 15 2021
End Date
August 1 2022
Last Update
November 1 2021
Active Locations (2)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9
2
Rouge Valley Hyperbaric Medical Centre
Scarborough Village, Ontario, Canada, M1E 5E9