The Use of Hyperbaric Oxygen Therapy (HBOT) for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Normalization of oxygen
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Investigate whether hyperbaric oxygen therapy treatment can become a viable treatment option for COVID-19. If successful, providers will be able to provide future COVID-19 patients with mild-to-moderate respiratory distress hyperbaric oxygen therapy in order to help avoid mechanical ventilation
Detailed Description
Using the Monoplace Hyperbaric Oxygen Chambers we will be providing COVID- 19 positive patients with mild-to-moderate distress 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatments. A comparison will be made using a historical cohort not receiving HBOT. Data will be collected to determine whether or not HBOT is of any benefit to COVID-19 positive patient with mild-to-moderate respiratory distress. Study Group: Provide 100% oxygen at 2.0 ATA for 90 minutes on consecutive days for a total of up to 5 treatment to COVID-19 patients meeting inclusion criteria Control Group: Any COVID-19 positive patient meeting study inclusion criteria that does not receive HBOT (historical) The control group is further defined as patients who were previously treated for COVID-19 at Morton Hospital that did not receive hyperbaric oxygen therapy. This will require accessing medical records to obtain patient information to establish the historical control data metric. Study outcome measures: * Time to normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air) * Mortality * Days free of invasive mechanical ventilation
Investigators
Eligibility Criteria
Inclusion Criteria
- •Verified COVID-19 infection
- •Patient w/02 dependence of less than or equal to 6 liter/min to maintain pulse ox greater than or equal to 92% or arterial gas w/PA02 greater than 60mm HG
Exclusion Criteria
- •Not diagnosed w/COVID-19 infection
- •Pregnancy
- •DNR or other restrictions in escalation of level of care
- •Contraindication for HBO
- •Blood pressure parameters which are deemed unstable by clinical team
- •Patients who require continuous ECG and/or continuous blood pressure monitoring, and with arterial lines
- •Patients requiring rewarming
- •Patients requiring any kind of invasive catheter/pressure monitoring
- •Patients requiring continuous support of intravenous medication
- •Minor subject (less than 18 years old)
Outcomes
Primary Outcomes
Normalization of oxygen
Time Frame: through study completion, an average of 1 year
normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
Secondary Outcomes
- Days free of invasive mechanical ventilation(through study completion, an average of 1 year)
- Mortality(through study completion, an average of 1 year)