Treating Spinal Cord Injury With Early Normobaric Hyperoxia
ConditionTraumatic Spinal Cord Injuries
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Normobaric Hyperoxia
Other interventionIntermittent 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of early normobaric hyperoxic therapy
Proportion of subjects receiving first normobaric hyperoxia therapy.
Time frame
24 hours from injury2
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 days3
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 periodSecondary outcomes
1
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 days2
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 period3
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.4
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 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov