Airway management and anaesthetic interventions for children with cleft lip and/or palate undergoing general anaesthesia: Protocol for a systematic review and meta-analysis
Sharmin Akter Sumi, Kazi Mahzabin Arin, Shahriar Mohd Shams, Tanzila Rafique, Keertika Orchi, Arna Chowdhury, Mohammad Meshbahur Rahman, Md Atiqul HaqueBackground
Children with cleft lip and/or palate may present unique challenges during perioperative airway management because of altered upper-airway and craniofacial anatomy. These children frequently undergo surgical procedures requiring general anaesthesia and airway instrumentation. Several airway-management and anaesthetic techniques have been evaluated to facilitate tracheal intubation and reduce perioperative airway complications, but the comparative evidence from randomised controlled trials has not been systematically evaluated.
Methods
This systematic review and meta-analysis will include randomised controlled trials involving children < 18 years with cleft lip and/or palate undergoing general anaesthesia. Eligible studies will compare alternative techniques or devices for airway management or other anaesthetic strategies between two groups of cleft lip/palate patients. The primary outcome will be difficulty in tracheal intubation. Where definitions vary substantially, outcomes will be analysed separately or synthesised narratively. Secondary outcomes will include difficult mask ventilation, oxygen desaturation, airway obstruction, difficult laryngoscopy, first-attempt intubation success, number of intubation attempts, time to successful intubation or airway establishment, failed intubation and other perioperative airway or respiratory adverse events. Two reviewers will independently select RCTs, extract data and assess risk of bias. Risk of bias will be evaluated using the Cochrane Risk of Bias 2 tool. Random-effects meta-analysis will be performed where clinically appropriate. Risk ratios will be used for dichotomous outcomes and mean differences or standardized mean differences for continuous outcomes. Certainty of evidence for important outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Registration and review status
The review was prospectively registered in PROSPERO on 10 March 2026 (CRD420261326076). Full-text screening and data extraction are ongoing and not yet complete. Protocol amendments are documented transparently in PROSPERO.