Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800120
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2020-11-13
Brief Title:
Use of Hyperbaric Oxygen Therapy to Treat COVID-19 Patients With Respiratory Distress
Sponsor:
Steward St Elizabeths Medical Center of Boston Inc
Organization:
Steward St Elizabeths Medical Center of Boston Inc
Study Overview
Official Title:
The Use of Hyperbaric Oxygen Therapy HBOT for the Treatment of COVID-19 Patients With Mild-to-moderate Respiratory Distress
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBOT
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 20 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 20 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 wPa02 greater than 60mmHG on air
Mortality
Days free of invasive mechanical ventilation
Study Group Provide 100 oxygen at 20 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 wPa02 greater than 60mmHG on air
Mortality
Days free of invasive mechanical ventilation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None