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Recruiting NCT07465302

Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Phase II Interventional Traumatic Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Normobaric Hyperoxia.
Who it may be relevant to
Registry conditions: Traumatic Spinal Cord Injuries. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial

Overview

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.

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.

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]
  • 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]
  • Preliminary safety of intermittent normobaric hyperoxia [Time frame: From completion of first treatment to end of 6 month follow up period]
Secondary outcome measures (6)
  • Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration [Time frame: From enrollment to the end of intervention period at 5 days]
  • Exploratory safety objectives [Time frame: From enrollment to end of 6 month follow up period]
  • Feasibility - Timely Placement of Lumbar Drain [Time frame: Time of injury to 24hr post injury.]
  • Feasibility - Completion of Required Monitoring Lines [Time frame: Day 0 to day 5]
  • Protocol Adherence - Sampling Deviations [Time frame: Enrollment to end of 6 month follow up period]
  • Sample Handling - Discarded Specimens [Time frame: From enrollment to end of 6 month follow up period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Florida — Gainesville

Identifiers

NCT: NCT07465302 · IRB202400873 · 4R00GM159353-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗