NCT07465302 · University of Florida
Treating Spinal Cord Injury With Early Normobaric Hyperoxia
(SpiCoH)
What this study is about
SpiCoH is a phase IIa, single center, where both patients and doctors know the treatment given, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and/or thoracic spinal cord injury.
View original scientific 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.
Interventions
OTHER
Normobaric Hyperoxia
Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.
Primary outcome measures
Feasibility of early normobaric hyperoxic therapy
Time frame: 24 hours from injury
Proportion of subjects receiving first normobaric hyperoxia therapy.
Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically
Time frame: From enrollment to the end of intervention period at 5 days
Serial PaO2
Preliminary safety of intermittent normobaric hyperoxia
Time frame: From completion of first treatment to end of 6 month follow up period
Four-point end-organ toxicity surveillance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Capacity to initiate the study intervention within 24 hours of injury
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
- 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
- Gainesville, Florida
Collaborators
National Institute of General Medical Sciences (NIGMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations