Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress (HBOT)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by

About this trial
This is an interventional treatment trial for Covid19
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)
- Refusal to participate
- Signs of respiratory decompensation requiring intubation and mechanical ventilation
- 02 dependence greater than or equal to 6L/minute to obtain Sa02 greater than or equal to 92% or ABG w/Pa02 >60mmHg
Sites / Locations
- Morton Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study Group
Control Group
Arm Description
Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy
Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy
Outcomes
Primary Outcome Measures
Normalization of oxygen
normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
Secondary Outcome Measures
Mortality
Patient survival of COVID-19
Days free of invasive mechanical ventilation
The time which patient remains without the need for intubation
Full Information
NCT ID
NCT04800120
First Posted
November 13, 2020
Last Updated
February 1, 2023
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04800120
Brief Title
Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress
Acronym
HBOT
Official Title
The Use of Hyperbaric Oxygen Therapy (HBOT) for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Active Comparator
Arm Description
Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen Therapy
Other Intervention Name(s)
HBOT
Intervention Description
Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber
Primary Outcome Measure Information:
Title
Normalization of oxygen
Description
normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Mortality
Description
Patient survival of COVID-19
Time Frame
through study completion, an average of 1 year
Title
Days free of invasive mechanical ventilation
Description
The time which patient remains without the need for intubation
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Refusal to participate
Signs of respiratory decompensation requiring intubation and mechanical ventilation
02 dependence greater than or equal to 6L/minute to obtain Sa02 greater than or equal to 92% or ABG w/Pa02 >60mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Trelease, DNP
Organizational Affiliation
Steward Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morton Hospital
City
Taunton
State/Province
Massachusetts
ZIP/Postal Code
02780
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress
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