Endoscopic balloon dilation for subglottic or tracheal stenosis

Evidence on the safety of endoscopic balloon dilation for subglottic or tracheal stenosis is adequate. The most serious complication related to the procedure, independent of age, is tracheal laceration but this is well recognised.

• For babies, children, and young people, evidence on the efficacy of the procedure is adequate to support using it, provided that standard arrangements are in place for clinical governance, consent and audit. Find out what standard arrangements mean on the NICE interventional procedures guidance page.

• For adults, evidence on the efficacy of the procedure is limited. So, it 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.

Clinicians wanting to do endoscopic balloon dilation for subglottic or tracheal stenosis in adults should:

• Inform the clinical governance leads in their healthcare organisation.

• Give patients (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.

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

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

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

Healthcare organisations should:

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

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

This procedure should only be done in specialist centres by clinicians trained in the technique, and with anaesthesia and intensive care support.

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