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

Area of Science:

• Pediatric Anesthesiology
• Airway Management
• Critical Care Medicine

Background:

• The use of cuffed tracheal tubes (TTs) in pediatric patients remains a topic of debate.
• Existing evidence is insufficient to definitively guide the choice between cuffed and uncuffed TTs in young children.
• This study addresses the controversy surrounding cuffed TT use in pediatric airway management.

Purpose of the Study:

• To compare post-extubation morbidity, specifically stridor, between cuffed and uncuffed TTs in children.
• To evaluate and compare the rates of tracheal tube (TT) exchanges required for appropriate sizing.
• To assess the safety and efficacy of cuffed TTs in pediatric patients aged 0-5 years.

Main Methods:

• A prospective, randomized trial involving 2246 children aged 0-5 years across 24 European pediatric anesthesia centers.
• Patients were randomized to receive either cuffed (Microcuff PET) or uncuffed TTs.
• Key endpoints included post-extubation stridor incidence and TT exchange rates; cuff pressure was monitored and limited to 20 cm H2O.

Main Results:

• No significant difference in post-extubation stridor rates between cuffed (4.4%) and uncuffed (4.7%) TT groups (P=0.543).
• A significantly lower TT exchange rate was observed in the cuffed TT group (2.1%) compared to the uncuffed group (30.8%) (P<0.0001).
• The minimal cuff pressure required for airway seal was 10.6 (4.3) cm H2O, well within the safety limit.

Conclusions:

• Cuffed TTs provide a reliably sealed airway in small children at safe cuff pressures (
• The use of cuffed TTs significantly reduces the need for TT exchanges, simplifying airway management.
• Cuffed TTs do not increase the risk of post-extubation stridor in this pediatric population compared to uncuffed TTs.