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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Covid19

Intervention / Treatment
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* Other: Hyperbaric Oxygen Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br>Identified COVID 19 patients receiving the intervention of Hyperbaric Oxygen Therapy | Other: Hyperbaric Oxygen Therapy<br>* Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber<br>* Other names: HBOT;|
| No Intervention: Control Group<br>Historical control of COVID 19 patients who were previously treated and did not receiving Hyperbaric Oxygen Therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patient survival of COVID-19 | through study completion, an average of 1 year | 
| Days free of invasive mechanical ventilation | The time which patient remains without the need for intubation | through study completion, an average of 1 year |