Actively Recruiting
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Led by University of Florida · Updated on 2026-05-01
12
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form provided by participant or legally authorized representative
- Willingness to comply with all study procedures for the entire study duration
- Male or female aged 18 to 85 years
- Diagnosed with blunt or penetrating traumatic cervical and/or thoracic spinal cord injury with dural sac intact
- Awake and able to interact and follow commands
- American Spinal Injury Association Impairment Scale grades A, B, or C
- Requires mechanical ventilation as determined by treating physician
- Baseline arterial oxygen pressure (PaO2) greater than 80 mmHg before enrollment
- Able to start study treatment within 24 hours of injury
You will not qualify if you...
- Evidence of traumatic brain injury on CT or MRI, including subarachnoid hemorrhage, hematomas, intracranial hemorrhage, contusions, or cerebrovascular injury grades II-V
- American Spinal Injury Association Impairment Scale grades D or E at hospital arrival
- Persistent low oxygen levels requiring more than 40% oxygen to keep PaO2 above 80 mmHg
- Injuries preventing lumbar drain placement, such as infection at insertion site, high intracranial pressure, brain mass lesions, or blood clotting problems
- Pre-existing neurological conditions that affect neurologic or functional assessments
- Pre-existing respiratory or lung conditions that affect ventilation or recovery assessment
- Participation in another investigational or interventional study (observational studies allowed)
- Known pregnancy or positive pregnancy test
- Vulnerable populations such as prisoners or inmates
- Any other serious medical condition that could increase risks, affect study participation, or confound results as determined by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
A
Andrew Kline
CONTACT
R
Ralisa Pop
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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