Covid19
Conditions
Brief summary
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
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
Interventions
OTHERHyperbaric Oxygen Therapy
Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalization of oxygen | 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | through study completion, an average of 1 year | Patient survival of COVID-19 |
| Days free of invasive mechanical ventilation | through study completion, an average of 1 year | The time which patient remains without the need for intubation |
Countries
United States
Outcome results
None listed