Spinal Cord InjuriesNCT06244160
High Flow Oxygen Therapy After Spinal Cord Injury
A study testing High flow oxygen therapy in people with Spinal Cord Injuries and Respiratory Failure, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
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: 1. Is it possible to recruit patients to the study 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Respiratory Failure
- What is being tested?
- High flow oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury between C4 and T4 (Include ASIA A-D)
- Admitted to spinal injury ward within 24-48hours of injury
Who cannot join
- Aged under 18 years
- 3 or more rib fractures or flail
- Sternal fracture
- Concomitant lung injury
- Unable to gain informed consent from participant
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiff and Vale University Health Board
Cardiff, CF144XW
Paul Twose, MSc, TwosePW@cardiff.ac.uk
About this study
Official title: High Flow Oxygen Therapy After Spinal Cord Injury - Feasibility Study to Design a Pragmatic Randomised Controlled Trial Protocol
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:
- Is it possible to recruit patients to the study
- It is possible to follow the protocol in its current format
- What is the impact on those receiving the intervention.
Participants will be randomised to receive either standard care or high flow oxygen therapy for 10 days following inclusion.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries, Respiratory Failure
- Being tested
- High flow oxygen therapy
- Medical subject headings
- Spinal Cord Injuries, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygen therapyOther
High flow oxygen therapy delivered via nasal cannulae, at 50 litres flow with variable oxygen levels
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | High flow oxygen therapy delivered via nasal cannalue Receives: Other: High flow oxygen therapy |
| Control | No intervention | Standard care with oxygen therapy as required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Secondary outcomes (5)
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
Measured: 10 days
Physiotherapy time
Duration (minutes) of physiotherapy intervention during the study period
Measured: 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
Measured: 10 days
Pulmonary complications
Incidence of pulmonary complications following spinal cord injury using the brooks-braun classification
Measured: 10 days
Incidence of ICU admission
Incidence of ICU admission during the study period
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Apr 2024
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility randomised control trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paul Twose, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244160
- Sponsor's protocol ID
- 8713
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to for IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen Therapy After Spinal Cord Injury - Feasibility Study to Design a Pragmatic Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06244160
- Acronym / sponsor ID
- 8713
- Conditions
- Spinal Cord Injuries, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it possible to recruit patients to the study
- It is possible to follow the protocol in its current format
- What is the impact on those receiving the intervention.
Participants will be randomised to receive either standard care or high flow oxygen therapy for 10 days following inclusion.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: High flow oxygen therapyHigh flow oxygen therapy delivered via nasal cannalue |
| Control | No intervention | –Standard care with oxygen therapy as required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Spinal cord injury between C4 and T4 (Include ASIA A-D)
- Admitted to spinal injury ward within 24-48hours of injury
Key exclusion criteria (6 listed)
- Aged under 18 years
- 3 or more rib fractures or flail
- Sternal fracture
- Concomitant lung injury
- Unable to gain informed consent from participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow oxygen therapyHigh flow oxygen therapy delivered via nasal cannulae, at 50 litres flow with variable oxygen levels | Other | Intervention |
Primary outcome
Recruitment rates
Time frame: 10 days
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
5 secondary outcomes
To determine the acceptability of the intervention
Time frame: 10 days
Physiotherapy time
Time frame: 10 days
Frequency of physiotherapy interventions
Time frame: 10 days
Pulmonary complications
Time frame: 10 days
Incidence of ICU admission
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No. No plan to for IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Twose principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen therapy in people with Spinal Cord Injuries and Respiratory Failure, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Twose, MSc (07739315830, paul.twose@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.