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

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

Status

Completed

Conditions

Covid19

Treatments

Other: Hyperbaric Oxygen Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04800120

IRB Protocol #00800

Details and patient eligibility

About

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

Full 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

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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