3 Committee considerations

3 Committee considerations

The evidence

3.1

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 5 sources, which was discussed by the committee. The evidence included 4 non-randomised comparative studies and 1 analysis of the Avery Biomedical Devices database. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2

The professional experts and the committee considered the key efficacy outcomes to be: ventilator-free hours per day, tracheostomy decannulation, survival, respiratory infections, hospital admissions and quality of life.

3.3

The professional experts and the committee considered the key safety outcomes to be: device failure, revision surgery, phrenic nerve palsy and infections.

3.4

Patient commentary was sought but none was received.

Committee comments

3.5

This procedure can be done using a cervical or thoracic approach, and is usually done bilaterally.

3.6

Most evidence was for traumatic high cervical spinal cord injury, but this procedure also has a role in spinal cord injury caused by non-traumatic conditions.

ISBN: 978-1-4731-6412-3