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OpenTrials
Completed

NCT Number: NCT04800120

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Morton Hospital

Taunton, Massachusetts, 02780, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Other names: HBOT

Primary outcomes

  1. Normalization of oxygen

    Time frame: through study completion, an average of 1 year

    normalize 02 requirement (ambient air pulse ox greater than or equal to 92% or ABG w/Pa02 greater than 60mmHG on air)

Secondary outcomes

  1. Mortality

    Time frame: through study completion, an average of 1 year

    Patient survival of COVID-19

  2. Days free of invasive mechanical ventilation

    Time frame: through study completion, an average of 1 year

    The time which patient remains without the need for intubation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: HBOT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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