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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
University of Florida
Gainesville, Florida, United States
RECRUITINGFeasibility 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.
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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