Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection
- Conditions
- COVID-19
- Interventions
- Device: Hyperbaric Oxygen Therapy
- Registration Number
- NCT04343183
- Lead Sponsor
- Ochsner Health System
- Brief Summary
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.
- Detailed Description
After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Adult inpatients >18 years old
- Positive PCR COVID-19 testing
- CT evidence of interstitial opacity
- Oxygen saturation <90% on room air
- pO2 = 55-70.
- Increased oxygen requirements
- Hemodynamic instability (MAP<65)
- Bradycardia (HR<50)
- History of seizure disorder
- Pneumothorax
- GFR<30
- Hemodialysis
- Refractory anxiety/claustrophobia
- Current pregnancy
- Uncorrectable hypoglycemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HBOT treatment group Hyperbaric Oxygen Therapy Patients will receive hyperbaric oxygen therapy
- Primary Outcome Measures
Name Time Method Decrease incidence of intubation by 30% or greater one month Compare rates of intubation between treatment and control groups
- Secondary Outcome Measures
Name Time Method Decrease renal injury one month Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups
Trial Locations
- Locations (1)
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States