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

NCT ID: NCT04800120

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-03-01

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

Conditions

Covid19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy

Group Type: ACTIVE_COMPARATOR

Hyperbaric Oxygen Therapy

Intervention Type: OTHER

Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyperbaric Oxygen Therapy

Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Intervention Type: OTHER

Other Intervention Names

HBOT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill Trelease, DNP

Role: PRINCIPAL_INVESTIGATOR

Steward Healthcare

Locations

Morton Hospital

Taunton, Massachusetts, United States

Countries

United States

Other Identifiers

IRB Protocol #00800

Identifier Type: -

Identifier Source: org_study_id