A Phase 2 interventional study of Normobaric Hyperoxia in Traumatic Spinal Cord Injuries, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
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.
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.
115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.
This study's planned enrollment of 12 is below the median of 48 across 82 interventional studies indexed under Hyperoxia.
Browse Hyperoxia studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normobaric hyperoxia
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.
Feasibility of early normobaric hyperoxic therapy
Proportion of subjects receiving first normobaric hyperoxia therapy.
Time frame: 24 hours from injury
Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically
Serial PaO2
Time frame: From enrollment to the end of intervention period at 5 days
Preliminary safety of intermittent normobaric hyperoxia
Four-point end-organ toxicity surveillance.
Time frame: From completion of first treatment to end of 6 month follow up period
Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration
Serial PaO2. Proportion of subjects receiving all 10 planned normobaric hyperoxia treatments.
Time frame: From enrollment to the end of intervention period at 5 days
Exploratory safety objectives
Rates of study termination from demonstrated signs of organ injury attributable to hyperoxia determined by safety monitoring board
Time frame: From enrollment to end of 6 month follow up period
Feasibility - Timely Placement of Lumbar Drain
Proportion of subjects with lumbar drain placed before initiation of normobaric hyperoxia.
Time frame: Time of injury to 24hr post injury.
Feasibility - Completion of Required Monitoring Lines
Proportion of subjects with lumbar drain and arterial line for the duration of 5-day intervention period.
Time frame: Day 0 to day 5
Protocol Adherence - Sampling Deviations
Rate of protocol violations or deviations related to missing samples or samples obtained outside the planned schedule for blood and/or CSF.
Time frame: Enrollment to end of 6 month follow up period
Sample Handling - Discarded Specimens
Rate of discarded CSF or blood samples
Time frame: From enrollment to end of 6 month follow up period
Plan to share: Yes — Individual participant data (IPD) underlying the primary results of this study-including de-identified clinical, physiologic, and outcome variables-will be made available following publication of the main results. Data will be shared in accordance with institutional policies and applicable regulations after all direct identifiers have been removed using a standardized de-identification protocol. The curated dataset, accompanying data dictionary, and analytic code (when applicable) will be deposited in the National Spinal Cord Injury Statistical Center (https://sites.uab.edu/nscisc/), where they will be accessible under a controlled-access model. Qualified researchers may request access by submitting a brief proposal outlining the intended use of the data; requests will be reviewed by the study team to ensure scientific validity and compliance with participant privacy protections. Data will remain available for the duration required by institutional policy.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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