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 range18 Years – 85 Years

SexALL

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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
✕. Persistent hypoxia requiring \>40% FiO2 to maintain PaO2 \>80 mmHg
✕. Concurrent injuries contraindicating lumbar drain placement, including, but not limited to: signs of infection at insertion site, elevated intracranial pressure, supratentorial mass lesion with mass effect, posterior fossa mass or uncorrected coagulopathy (thrombocytopenia \<100,000/μL or International Normalized Ratio \>1.5)
✕. Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes
✕. Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery
✕. Participation in a concurrent investigational/interventional study (observational studies allowed)
✕. Known to be pregnant, or with a positive pregnancy test

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