NCT07465302

Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Spinal Cord Injuries

Interventions

Type	Name	Description
OTHER	Normobaric Hyperoxia	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-30
• Completion: 2028-09-30
• First posted: 2026-03-11
• Last updated: 2026-03-11