Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:30 AM
Study NCT ID:
NCT07465302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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:
SpiCoH
Brief Summary:
SpiCoH is a phase IIa, single center, open-label, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and/or thoracic spinal cord injury.
Detailed Description:
Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 4R00GM159353-02 | NIH | None | https://reporter.nih.gov/quic… | View |