Objective To assess the current evidence for the efficacy of care bundles in reducing unplanned extubations (UEs) in critically ill children.

Design Systematic review according to the Cochrane guidelines and meta-analysis using random-effects modelling.

Methods We searched MEDLINE, EMBASE, CINAHL, Web of Science, Scopus, Cochrane and SciELO databases from inception until April 2021. We conducted a quality appraisal for each study using the Newcastle–Ottawa Scale and Standards for Quality Improvement Reporting Excellence (SQUIRE) V.2.0 checklist.

Main outcome The primary outcome measure was UE rates per 100 intubation days.

Results We screened 10 091 records and finally included 11 studies. Six studies were pre/post-intervention studies, and five were interrupted time-series studies. The methodological quality was ‘good’ in 70%, and the remaining as ‘fair’ (30%). The most frequently used implementation strategies were staff education (100%), root cause analysis (100%), and audit and feedback (82%). Key bundle care components comprised identification of high-risk patients, endotracheal tube care and sedation protocol. Not all studies fully completed the SQUIRE V.2.0 checklist. Meta-analysis revealed a reduction in UE rate following the introduction of care bundles (rate ratio: 0.40 (95% CI: 0.19 to 0.84); p=0.02), which equates to a 60% reduction in UE rates.

Conclusions We found that identifying high-risk patients, endotracheal tube care and protocol-directed sedation are core elements in care bundles for preventing UEs. However, there are several methodological gaps in the literature, including poor evaluation of adherence to bundle components. Future studies should address these gaps to strengthen their validity.