High-flow oxygen treatment after spinal cord injury
High Flow Oxygen Therapy After Spinal Cord Injury - Feasibility Study to Design a Pragmatic Randomised Controlled Trial Protocol
This study will test whether giving high-flow oxygen for 10 days helps people with recent neck or upper-back (C4–T4) spinal cord injuries avoid breathing complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardiff and Vale University Health Board Government |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT06244160 on ClinicalTrials.gov |
What this trial studies
This randomized feasibility trial will assign adults with acute cervical or upper thoracic spinal cord injury (C4–T4) to receive either standard care or high-flow oxygen therapy for 10 days after enrollment. The primary goals are to determine if patients can be recruited, if the protocol can be followed as written, and to collect preliminary data on the intervention's effects on respiratory outcomes. Key inclusion criteria include admission to the spinal injury ward within 24–48 hours of injury and ASIA grades A–D, while major chest trauma, concomitant lung injury, undrained pneumothorax, or facial/skull-base injuries are excluded. The single-site study is run by Cardiff and Vale University Health Board in Cardiff, UK.
Who should consider this trial
Good fit: Adults (18 and over) with an acute spinal cord injury between C4 and T4 (ASIA A–D) admitted to the spinal injury ward within 24–48 hours of injury are the intended participants.
Not a fit: Patients with major thoracic trauma (three or more rib fractures, flail chest, sternal fracture), concomitant lung injury, undrained pneumothorax, facial or skull-base fractures, nasal obstruction or other contraindications to high-flow therapy, or those admitted later than 48 hours are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, high-flow oxygen could reduce early respiratory complications such as atelectasis, pneumonia, and respiratory failure and improve recovery after high cervical/upper thoracic spinal cord injury.
How similar studies have performed: High-flow oxygen has shown benefit in other forms of acute respiratory failure, but its use specifically after acute cervical or upper thoracic spinal cord injury has not been well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Spinal cord injury between C4 and T4 (Include ASIA A-D) 2. Admitted to spinal injury ward within 24-48hours of injury Exclusion Criteria: 1. Aged under 18 years 2. 3 or more rib fractures or flail 3. Sternal fracture 4. Concomitant lung injury 5. Unable to gain informed consent from participant 6. Contra-indication to using high flow therapy e.g., undrained pneumothorax, facial fractures, nasal obstruction, CSF leak, suspected or confirmed base of skull fracture, active epistaxis or recent functional endoscopic sinus surgery.
Where this trial is running
Cardiff
- Cardiff and Vale University Health Board — Cardiff, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Paul Twose — Cardiff and Vale University Health Board
- Study coordinator: Paul Twose, MSc
- Email: paul.twose@wales.nhs.uk
- Phone: 07739315830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.