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

Not Applicable

Completed

• Conditions: Covid19

• Registration Number: NCT04800120
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

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

Study Timeline

• Study First Submitted: 2020-11-13
• Study Start: 2021-02-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Morton Hospital; 🇺🇸 Taunton, Massachusetts, United States