Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
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: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: 18 years — 65 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
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This proof-of-principle study will determine if breathing an increased concentration of oxygen above the concentration in normal room air results in changes in the sensory and motor function in people with subacute or chronic, severe spinal cord injury (SCI).
Detailed description
This proof-of-principle study will include a small number of participants with subacute or chronic (\>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen.
Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects.
If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken
Interventions
- Drug Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
Participants will receive oxygen (99%) or room air (placebo) delivered through a face mask at a flow rate of 10 litres/min for 2 minutes. The participants will be exposed twice to both conditions over 4 experiments at a minimum of 2 week intervals between each testing session.
Primary outcome measures
- Skin Sensation [Time frame: Pre-intervention (exposure to high oxygen)]
- Skin Sensation [Time frame: Immediately after intervention (exposure to high oxygen)]
- Skin Sensation [Time frame: Pre-intervention (exposure to room air)]
- Skin Sensation [Time frame: Immediately after intervention (exposure to room air)]
Secondary outcome measures (4)
- Reflex Excitability [Time frame: Pre-intervention (exposure to high oxygen)]
- Reflex Excitability [Time frame: Immediately after intervention (exposure to high oxygen)]
- Reflex Excitability [Time frame: Pre-intervention (exposure to room air)]
- Reflex Excitability [Time frame: Immediately after intervention (exposure to room air)]
Eligibility criteria
Inclusion criteria
- Individuals with traumatic SCI with onset ≥3 months prior,
- Between 18 - 65 yr old,
- ASIA Impairment Scale at discharge classified as A, B or C,
- Injury level between C5 and T10,
- Able to give informed, written consent.
Exclusion criteria
- Frequent uncontrolled autonomic dysreflexia,
- Uncontrolled high blood pressure,
- Cardiac or cardiovascular disease,
- Cancer,
- Active urinary tract infection,
- Active pressure sores,
- Signs of deep vein thrombosis in the legs,
- Severe swelling of the feet and/or legs,
- Severe cognitive impairment,
- Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection,
- Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- University of Alberta, Clinical Sciences Bldg — Edmonton
Identifiers
NCT: NCT05467215 · Pro00061817