Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619717
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Optimal Number of Hyperbaric Oxygen Treatments for Carbon Monoxide Poisoning
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning An Open-label Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades Initial landmark studies showed a decrease in the incidence of DNS with a single treatment and also with three treatments over the course of 24 hours These two strategies have continued to be used widely without further evidence comparing them in a direct fashion Retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments The investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes
Detailed Description:
HBO is a niche treatment modality especially in Canada There are few sites which offer this care and as such treatment often carries significant logistical challenges Since 2021 the HBO unit at the Misericordia hospital has averaged 49 patients per year being treated for CO poisoning This HBO unit provides coverage to patients within Alberta Saskatchewan Manitoba Yukon and Northwest Territories Due to the significant barriers to treatment including the high cost to the public system it is important to clearly understand how to best treat these patients
Purpose
The aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning
Purpose
The aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None