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NCT Number: NCT06244160

High Flow Oxygen Therapy After Spinal Cord Injury

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. It is possible to follow the protocol in its current format 3. 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiff and Vale University Health Board

Cardiff, CF144XW, United Kingdom

Location status: Recruiting

Location contact

Paul Twose, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spinal cord injury between C4 and T4 (Include ASIA A-D)
  • Admitted to spinal injury ward within 24-48hours of injury

Exclusion criteria

  • 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.

Treatment and study plan

High Flow Oxygen Therapy

Other

High flow oxygen therapy delivered via nasal cannulae, at 50 litres flow with variable oxygen levels

Primary outcomes

  1. 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

Secondary outcomes

  1. To determine the acceptability of the intervention

    Time frame: 10 days

    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

  2. Physiotherapy time

    Time frame: 10 days

    Duration (minutes) of physiotherapy intervention during the study period

  3. Frequency of physiotherapy interventions

    Time frame: 10 days

    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

  4. Pulmonary complications

    Time frame: 10 days

    Incidence of pulmonary complications following spinal cord injury using the brooks-braun classification

  5. Incidence of ICU admission

    Time frame: 10 days

    Incidence of ICU admission during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Twose, MSc

CONTACT

[email protected]

07739315830

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Registry information

Official study title

High Flow Oxygen Therapy After Spinal Cord Injury - Feasibility Study to Design a Pragmatic Randomised Controlled Trial Protocol

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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