HBOT: Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress

Sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800120

Collaborator

(none)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Hyperbaric Oxygen Therapy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention 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)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)

Primary Purpose:

Treatment

Official Title:

The Use of Hyperbaric Oxygen Therapy (HBOT) for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress

Actual Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study Group Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy	Other: Hyperbaric Oxygen Therapy Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber Other Names: HBOT
No Intervention: Control Group Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy

Arm

Intervention/Treatment

Active Comparator: Study Group

Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy

Other: Hyperbaric Oxygen Therapy

Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Other Names:

HBOT

No Intervention: Control Group

Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcome Measures

Normalization of oxygen [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 Outcome Measures

Mortality [through study completion, an average of 1 year]
Patient survival of COVID-19
Days free of invasive mechanical ventilation [through study completion, an average of 1 year]
The time which patient remains without the need for intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Morton Hospital	Taunton	Massachusetts	United States	02780

Sponsors and Collaborators

Steward St. Elizabeth's Medical Center of Boston, Inc.

Investigators

Principal Investigator: Jill Trelease, DNP, Steward Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jill Trelease, Program Director, Center for Wound Healing at Morton Hospital, Steward St. Elizabeth's Medical Center of Boston, Inc.

ClinicalTrials.gov Identifier:

NCT04800120

Other Study ID Numbers:

IRB Protocol #00800

First Posted:

Mar 16, 2021

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 16, 2021