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

Covid19 Clinical Trial

— HBOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800120
• Other study ID #: IRB Protocol #00800
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2023
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Hyperbaric Oxygen Therapy
Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Locations

Country	Name	City	State
United States	Morton Hospital	Taunton	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

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