search
Back to results

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
Steward St. Elizabeth's Medical Center of Boston, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 13, 2020
Last Updated
February 1, 2023
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
search

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

We'll reach out to this number within 24 hrs