Print

Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
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)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04800120
Status
Completed
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.