RecruitingPhase 2

Treating Spinal Cord Injury With Early Normobaric Hyperoxia

United States12 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision of signed and dated ICF by the subject or LAR
. Stated willingness to comply with all study procedures for the duration of the study
. Male or female subjects, aged ≥18 and ≤ 85 years
. Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)
. Awake and able to interact and follow commands
. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C
. Need for mechanical ventilation (MV), as determined by the treating physician
. Baseline PaO2 \>80 mmHg before enrollment

Exclusion criteria

. Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial hemorrhage, parenchymal contusions, and blunt cerebrovascular injury grades II-V
. AIS grades D or E at time of arrival to hospital

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of early normobaric hyperoxic therapy

Timeframe: 24 hours from injury

Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically

Timeframe: From enrollment to the end of intervention period at 5 days

Preliminary safety of intermittent normobaric hyperoxia

Timeframe: From completion of first treatment to end of 6 month follow up period

Trial details

NCT IDNCT07465302

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-30

Contact for this trial

Andrew Kline

352-273-9000 andrew.kline@neurosurgery.ufl.edu

View on ClinicalTrials.gov More Traumatic Spinal Cord Injuries trials