An interventional study of High flow oxygen therapy in Spinal Cord Injuries and Respiratory Failure, sponsored by Cardiff and Vale University Health Board. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Cardiff and Vale University Health Board · Not applicable, Interventional, and Prevention
The goal of this feasibility study is to learn about the ability to use a different form of oxygen therapy (known as high flow oxygen therapy) in patients who have a spinal cord injury in the upper back or neck.
The main questions it aims to answer are:
Participants will be randomised to receive either standard care or high flow oxygen therapy for 10 days following inclusion.
In the UK, the annual incidence of acute spinal cord injury (SCI) is 19 new cases per million population, contributing to an estimated 50,000 people who are currently living with SCI1. Trauma is the most common cause of SCI, predominantly from falls and road traffic accidents. Damage to the spinal cord occurs both at the time of injury (primary) and in its aftermath (secondary). Effectively treating and preventing secondary cord injury, and managing complications associated with SCI, can make a significant improvement to patient outcomes.
Respiratory dysfunction is one of the most common medical complications, as well as the leading cause of reduced Quality of Life (QoL) and mortality, with literature indicating that 67% of individuals with a spinal cord injury present with respiratory complications in the acute stage.
The most common respiratory complications are: 1) atelectasis; 2) pneumonia; and 3) respiratory failure. A retrospective review of the patients with acute traumatic spinal cord injuries at C5-T5 level showed a higher prevalence of respiratory complications during the initial hospitalisation just after the injury and suggests the presence of previous respiratory disease, complete motor impairment
(AISA A-B) and coexistent thoracic trauma are a predictor of respiratory complications. Individuals with cervical and higher thoracic spinal cord injuries are more likely to develop respiratory complications, primarily due to diaphragm impairment.
Due to the above, patients have increased rates of infection, poor sputum clearance and inadequate humidification. These complications lead to prolonged admissions, admission to intensive care and considerable healthcare related costs. As such it is essential to develop new management protocols to reduce the occurrence of pulmonary complications
AIRVOTM (a form of non-invasive high flow oxygen therapy, HFOT), which delivers high flow heated and humidified oxygen and air via nasal cannula at a prescribed fraction of inspired oxygen and a maximum flow of 60 L/min, is an attractive alternative to conventional oxygen therapy. Previous studies have shown that HFOT therapy generates a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume, thus suggesting a possible alveolar recruitment associated with high-flow therapy. Although widely used in other clinical areas across the NHS, HFOT delivered via the AIRVOTM system has yet to be evaluated in the spinal cord injury population.
Furthermore, HFNC oxygen therapy has been shown to improved swallowing function in a patient with dysphagia associated with respiratory-muscle paralysis following a SCI, further reducing the risk of aspiration and subsequent infection. It has been hypothesised that the use of HFNC prolongs the patient's apnoea tolerance time during swallowing and hence improves the timing of swallowing.
This study aims to explore the feasibility of using HFOT (delivered via AIRVOTM) therapy and compare to current treatment (conventional oxygen and humidification administration) for patients who have a spinal cord injury. The secondary outcomes will explore any provisional impacts on length of stay, requirement of admission to intensive care, antibiotic use, and physiotherapy requirements including use of cough augmentation e.g., Mechanical Insufflation - Exsufflation.
The results of this proof-of-concept study will be used to further develop local protocols and develop a multi-site research protocol for grant application.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 30 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Cardiff and Vale University Health Board is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High flow oxygen therapy delivered via nasal cannalue
Other: High flow oxygen therapy
Standard care with oxygen therapy as required.
High flow oxygen therapy delivered via nasal cannulae, at 50 litres flow with variable oxygen levels
Recruitment rates
This will explore the ability to recruit eligible participants in a timely fashion as per the protocol. It will also capture the participant retainment rates during the study E.g., number of patients recruited, and % of those recruited completing study
Time frame: 10 days
To determine the acceptability of the intervention
To see if the protocol can be followed and patients can receive the intervention - do all patients receive the intervention as planned, or is there any cross-over of interventions. E.g. % of participants completing the intervention as planned
Time frame: 10 days
Physiotherapy time
Duration (minutes) of physiotherapy intervention during the study period
Time frame: 10 days
Frequency of physiotherapy interventions
To understand whether the chosen outcome measures are appropriate - is it appropriate and possible to capture the frequency of physiotherapy intervention during the study period
Time frame: 10 days
Pulmonary complications
Incidence of pulmonary complications following spinal cord injury using the brooks-braun classification
Time frame: 10 days
Incidence of ICU admission
Incidence of ICU admission during the study period
Time frame: 10 days
Plan to share: No — No plan to for IPD sharing
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Cardiff and Vale University Health Board