None listed
Conditions
Brief summary
A spinal cord injury is a devastating event, with approximately 350 new cases in Australia every year. Each injury has a lifetime cost of >$5m. More than half of these injuries will be caused by an injury to the cervical (neck) area of the spinal cord, termed tetraplegia. While tetraplegia is commonly associated with paralysis of all four limbs, paralysis also affects the major respiratory muscles, namely the diaphragm, abdominal and intercostal muscles. This reduces respiratory function, with associated complications a leading cause of illness and death for people with tetraplegia. Poor respiratory function leads to approximately 40% of people with tetraplegia requiring mechanical ventilation in the early stage of injury. This increases the likelihood of illness and death, delays rehabilitation and hospital discharge and costs an additional $2,000 per patient per day. The application of electrical pulses to the abdominal muscles, called Abdominal Functional Electrical Stimulation (Abdominal FES) improves respiratory function in tetraplegia. We have shown that Abdominal FES is a feasible technique to assist ventilator weaning for this group. Despite these positive results, a lack of data from large trials has prevented Abdominal FES being adopted as a standard treatment. We propose an international randomised controlled trial to assess whether Abdominal FES reduces mechanical ventilation duration in people with tetraplegia. Such a reduction has the potential to improve the health and rehabilitation prospects of people with tetraplegia globally, and result in a significant cost saving for health care providers. The final outcome of this project will be the development of an Abdominal FES treatment program, facilitating the successful translation of this research into worldwide clinical practice.
Interventions
The abdominal muscles are the primary muscle group used during forced exhalation. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function and may assist weaning from mechanical ventilation in spinal cord injury. However, the effect of Abdominal FES on mechanical ventilation duration has yet to be studied in a fully powered trial. We hypothesise that Abdominal FES will reduce mechanical ventilation duratio
The abdominal muscles are the primary muscle group used during forced exhalation. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function and may assist weaning from mechanical ventilation in spinal cord injury. However, the effect of Abdominal FES on mechanical ventilation duration has yet to be studied in a fully powered trial. We hypothesise that Abdominal FES will reduce mechanical ventilation duration after spinal cord injury. Two hundred and 93 participants will be recruited to this multi-site randomised, placebo controlled pilot trial. Participants with a new cervical spinal cord injury will be recruited 5-10 days post injury. 147 patients will be randomly allocated to receive Abdominal FES and 146 will receive a placebo. In the Abdominal FES group, Abdominal FES will be applied for 45 minutes per day, 5 days per week, until discharge from the ICU or for 8 weeks, whatever comes first. Adherence will be monitored using a daily training diary. Specifically, Abdominal FES will be delivered, via electrodes placed over the posterolateral surface of the abdomen. The stimulation amplitude will initially be set to 60 mA (50 Hz), which corresponds to 90% of the maximum amplitude that was tolerated by healthy volunteers in a previous study. If this amplitude results in discomfort to the patient (based on clinical judgement) then it will be reduced as necessary. Stimulation amplitude will be evaluated every 5 minutes to ensure that stimulation is still tolerable and causing a suitable muscle contraction. Stimulation will be applied by a local physiotherapist at each site.
Sponsors
Neuroscience Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 5-10 days post C3-C8 cervical spinal cord injury (i.e. tetraplegia) - over 18 years of age - mechanical ventilation dependence - no useful abdominal muscle movement
Exclusion criteria
- American Spinal Injuries Association Impairment Scale D (patients have near normal respiratory muscle function and low risk of respiratory complications, making the intervention redundant) - progressive neurological disease or chronic respiratory disease - physical obstacles that prevent Abdominal FES (e.g. pregnancy, abdominal trauma, pacemaker) - no response to Abdominal FES (e.g. lower motor neuron impairment) - uncontrolled hypertension (placing the patient at risk of autonomic dysreflexia)
Outcome results
None listed