Paediatric cuffed tube study
Research type
Research Study
Full title
Reducing intra-operative pressure variations in paediatric MicroCuff endotracheal tube cuffs
IRAS ID
198427
Contact name
James Armstrong
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
During surgery under anaesthesia, children need a safe, open airway. One way to achieve this is by placing a breathing tube (endotracheal (ET) tube) within the airway with an inflatable balloon at the tip, preventing air leak and protecting the airway from soiling. \n\nThe main concern with cuffed ET tubes in children is ensuring too much pressure isn’t generated by the cuff, possibly damaging the windpipes lining. This can cause problems around the end of surgery and, rarely, permanent narrowing. \n\nStandard practice is to inflate the ET cuff with air. Published evidence proves that the volume of air in this cuff can change during anaesthesia, thereby changing the pressure within it. A number of methods to prevent this pressure change have been suggested, with one of the most successful being the use of water in the cuff instead of air, although this is not standard practice. Guidelines recommend cuff pressure is monitored, but preventing changes would be the gold standard.\n\nPaediatric tube cuffs differ in design and material from adult cuffs. Evidence exists that these tubes show similar increases in pressure during anaesthesia, but there is no published work looking at ways to address this.\n\nWe aim to assess the effects of using water to inflate the cuff of paediatric ET tubes, in comparison to air.\nChildren having surgery that already need an ET tube will be randomised to have the cuff inflated with air (standard practice) or water. Pressure will be continuously monitored and any interventions needed to keep it below a safe limit will be noted. Pressures will not be allowed to go above safe levels during the study. After their operation, older children will be asked to report any complications that could be linked to high cuff pressures (e.g. sore throat, hoarseness or difficulty swallowing).
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1310
Date of REC Opinion
1 Sep 2017
REC opinion
Further Information Favourable Opinion