Treating Spinal Cord Injury With Early Normobaric Hyperoxia (SpiCoH)

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Spinal Cord Injuries
• Intervention / Treatment: Other: Normobaric Hyperoxia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andrew Kline; Phone Number: 352-273-9000; Email: andrew.kline@neurosurgery.ufl.edu
• Study Contact Backup: Name: Ralisa Pop; Phone Number: (352) 294-5693; Email: Ralisa.Pop@neurology.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Contact: Andrew Kline; Phone Number: 724-496-8034; Email: andrew.kline@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of early normobaric hyperoxic therapy	Proportion of subjects receiving first normobaric hyperoxia therapy.	24 hours from injury
Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically	Serial PaO2	From enrollment to the end of intervention period at 5 days
Preliminary safety of intermittent normobaric hyperoxia	Four-point end-organ toxicity surveillance.	From completion of first treatment to end of 6 month follow up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration	Serial PaO2. Proportion of subjects receiving all 10 planned normobaric hyperoxia treatments.	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	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 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.	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.	Enrollment to end of 6 month follow up period
Sample Handling - Discarded Specimens	Rate of discarded CSF or blood samples	From enrollment to end of 6 month follow up period

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Carolina Maciel, MD, MSCR, University of Florida; Principal Investigator: Katharina Busl, MD, MS, University of Florida; Principal Investigator: Daryl Fields, MD, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; normobaric hyperoxia; hyperoxia; traumatic spinal cord injury; FiO2 100%
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hyperoxia
• Other Study ID Numbers: IRB202400873; 4R00GM159353-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No