Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
University of Florida
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.
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.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated ICF by the subject or LAR 2. Stated willingness to comply with all study procedures for the duration of the study 3. Male or female subjects, aged ≥18 and ≤ 85 years 4. Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity) 5. Awake and able to interact and follow commands 6. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C 7. Need for mechanical ventilation (MV), as determined by the treating physician 8. Baseline PaO2 \>80 mmHg before enro…
Interventions
- OtherNormobaric 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.
Location
- University of FloridaGainesville, Florida