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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Hyperbaric Oxygen Therapy

• 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

Arm && Interventions

Group	Intervention	Description
Study Group	Hyperbaric Oxygen Therapy	Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy

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

Trial Locations

Locations (1)

Morton Hospital; 🇺🇸 Taunton, Massachusetts, United States