Early normobaric hyperoxia for traumatic cervical or thoracic spinal cord injury
Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
This study tests whether giving short, repeated sessions of 100% oxygen to people on ventilators after recent traumatic cervical or thoracic spinal cord injuries helps their recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07465302 on ClinicalTrials.gov |
What this trial studies
This phase IIa, single-center, open-label trial delivers intermittent normobaric hyperoxia (FiO2 100%) to mechanically ventilated adults with acute cervical or thoracic traumatic spinal cord injury. Participants receive two 4.5-hour oxygen sessions per day for five consecutive days, with one session pair separated by a minimum 90 minutes and the other by about 10 hours. Eligible patients are adults (18–85) with AIS grades A–C who are awake, can follow commands, have baseline PaO2 >80 mmHg, and can start treatment within 24 hours of injury, while those with traumatic brain injury are excluded. The trial collects biomarker and clinical safety signals to see if this dosing schedule appears promising for reducing secondary injury.
Who should consider this trial
Good fit: Adults 18–85 with recent blunt or penetrating cervical or thoracic spinal cord injury (AIS A–C), who are awake, require mechanical ventilation, have PaO2 >80 mmHg, and can begin treatment within 24 hours of injury.
Not a fit: Patients with concurrent traumatic brain injury, AIS D–E, those not on mechanical ventilation, those who cannot be treated within the 24-hour window, or those with inadequate baseline oxygenation are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could limit secondary spinal cord damage and improve neurological recovery after acute injury.
How similar studies have performed: Preclinical work and a few small early-phase human reports hint that increased oxygen can affect spinal cord injury biology, but clinical evidence for this exact intermittent normobaric hyperoxia protocol is limited and largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 enrollment 9. Capacity to initiate the study intervention within 24 hours of injury Exclusion Criteria: 1. 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 2. AIS grades D or E at time of arrival to hospital 3. Persistent hypoxia requiring \>40% FiO2 to maintain PaO2 \>80 mmHg 4. 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) 5. Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes 6. Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery 7. Participation in a concurrent investigational/interventional study (observational studies allowed) 8. Known to be pregnant, or with a positive pregnancy test 9. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB) 10. Patient has any other clinically significant medical condition as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Carolina Maciel, MD, MSCR — University of Florida
- Study coordinator: Andrew Kline
- Email: andrew.kline@neurosurgery.ufl.edu
- Phone: 352-273-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.