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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Hyperbaric Oxygen Therapy

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Trelease, DNP; Phone Number: 508-828-7000; Email: jill.trelease@steward.org

Study Locations

• United States
  • Massachusetts
    • Taunton, Massachusetts, United States, 02780
      • Morton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Investigators: Principal Investigator: Jill Trelease, DNP, Steward Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB Protocol #00800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No