Scientists from NMPCE have led a national project to study the safety and efficacy of using endoscopic balloon dilatation to treat narrowing of airways in children. The study is reported in a recent paper, written in collaboration with clinical colleagues from Newcastle, Alder Hey, Guy’s & St Thomas’, Birmingham Women’s and Children’s Hospital, Sheffield Children’s Hospital, Great Ormond Street and the National Institute of Health and Care Excellence. It found that procedural success was achieved in 88% of patients and 6% of procedures were associated with in-hospital complications, with no long-term adverse safety concerns. The study provides important evidence that will support updates to national guidance.
In 2012, the National Institute for Health and Care Excellence (NICE) published interventional procedure guidance on Endoscopic balloon dilatation for subglottic and tracheal stenosis, highlighting a lack of evidence on the safety and efficacy of the procedure in terms of quantity and quality. In response to this, the Airway Intervention Registry (AIR) was developed, aiming to collect observational data on balloon dilatation procedures conducted in NHS hospitals across the UK.
The AIR platform is hosted by NMPCE, and was developed in collaboration with NICE, professional societies (ENT UK, BAPO), ENT consultants and patient representation. The balloon dilatation data collection opened on April 2015, and was adopted onto the NIHR Clinical Research Network portfolio on November 2016. A total of 10 NHS Hospitals contributed to the data collection, reporting outcomes from 133 balloon dilatation procedures conducted in 59 paediatric patients in 10 NHS hospitals. The database was then linked to Hospital Episode Statistics (using pseudonymised methodology) to ensure comprehensive follow-up. This makes AIR the largest prospective multi-centre study of balloon dilatation in the UK.
The study found that balloon dilation increases the size of the airway intraoperatively, and is associated with long term increase in airway diameter. Procedural success (defined as not requiring tracheostomy and avoiding open airway surgery) was achieved in 88% of patients without tracheostomy undergoing primary treatment of stenosis. In-hospital complications occurred in 8/133 balloon dilatation procedures (6%), however no long-term adverse safety concerns. Our study suggests that the rate of complication in those without a tracheostomy exceeded the rate in those with, but our study was too small to show this conclusively. Pending further evidence, a precautionary approach would be to conduct balloon dilatation in large acute hospitals with paediatric intensive care facilities
Evidence from the AIR: balloon dilatation data collection has been shared with NICE and may inform the update of national guidance. The full paper is published as open access in Clinical Otolaryngology.