Treating Spinal Cord Injury With Early Normobaric Hyperoxia
Key facts
- Where
- Gainesville, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07465302, who can take part
Where in United States
- University of FloridaGainesville, United StatesContact: Andrew KlineTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Florida
- Trial code
- NCT07465302
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
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.
Inclusion: 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; Capacity to initiate the study intervention within 24 hours of injury.
Exclusion: 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); Participation in a concurrent investigational/interventional study (observational studies allowed); 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; 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; 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; AIS grades D or E at time of arrival to hospital; Persistent hypoxia requiring >40% FiO2 to maintain PaO2 >80 mmHg; Known to be pregnant, or with a positive pregnancy test; Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB).