Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children.

BACKGROUND The use of cuffed tracheal tubes (TTs) in small children is still controversial. The aim of this study was to compare post-extubation morbidity and TT exchange rates when using cuffed vs uncuffed tubes in small children. METHODS Patients aged from birth to 5 yr requiring general anaesthesia with TT intubation were included in 24 European paediatric anaesthesia centres. Patients were prospectively randomized into a cuffed TT group (Microcuff PET) and an uncuffed TT group (Mallinckrodt, Portex, Rüsch, Sheridan). Endpoints were incidence of post-extubation stridor and the number of TT exchanges to find an appropriate-sized tube. For cuffed TTs, minimal cuff pressure required to seal the airway was noted; maximal cuff pressure was limited at 20 cm H(2)O with a pressure release valve. Data are mean (SD). RESULTS A total of 2246 children were studied (1119/1127 cuffed/uncuffed). The age was 1.93 (1.48) yr in the cuffed and 1.87 (1.45) yr in the uncuffed groups. Post-extubation stridor was noted in 4.4% of patients with cuffed and in 4.7% with uncuffed TTs (P=0.543). TT exchange rate was 2.1% in the cuffed and 30.8% in the uncuffed groups (P<0.0001). Minimal cuff pressure required to seal the trachea was 10.6 (4.3) cm H(2)O. CONCLUSIONS The use of cuffed TTs in small children provides a reliably sealed airway at cuff pressures of <or=20 cm H(2)O, reduces the need for TT exchanges, and does not increase the risk for post-extubation stridor compared with uncuffed TTs.