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

Steward St. Elizabeth's Medical Center of Boston, Inc.6 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Hyperbaric Oxygen TherapyOTHER

Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Morton Hospital

Taunton, Massachusetts, United States

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

Mortality

Patient survival of COVID-19

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

Days free of invasive mechanical ventilation

The time which patient remains without the need for intubation

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

Data from ClinicalTrials.gov

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