Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Recruiting now · Phase 2

Conditions studied: Traumatic Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT07465302

Run by

University of Florida

People needed

12

Starts

2026-04-15

Expected to finish

2028-09-30

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
• 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 it is running

• University of Florida — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.