Guidance

1 Recommendations

1 Recommendations

1.1 Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.

1.2 Clinicians wanting to do intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries should:

  • Inform the clinical governance leads in their healthcare organisation.

  • Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.

  • Take account of NICE's advice on shared decision making and NICE's information for the public.

  • Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).

  • Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.

1.3 Healthcare organisations should:

  • Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.

  • Regularly review data on outcomes and safety for this procedure.

1.4 Patient selection should be done by a multidisciplinary team with experience in managing high spinal cord injury and in managing home ventilation.

1.5 The procedure should only be done by surgeons with experience and training in this procedure.

1.6 Report any problems with a medical device using the Medicines and Healthcare products Regulatory Agency's Yellow Card Scheme.

1.7 Further research should be randomised controlled trials or observational data from registries or other sources of real-world evidence.

Why the committee made these recommendations

The evidence for this procedure is limited because there is a lack of long-term data and no high-quality clinical trials. But the evidence does suggest that this procedure may improve quality of life and enable people to have some ventilator-free time each day. The evidence on safety includes reports of electrode insertion site infection and pneumonia, but it is not certain if pneumonia is directly caused by the procedure. More research will offer more evidence on safety and long-term outcomes.

High spinal cord injury is severely disabling. For people who are dependent on mechanical ventilation, this procedure offers one of few options that could enable them to have some ventilator-free time. So, this procedure is recommended but only with special arrangements.