ObjectiveThe purpose was to analyse the effectiveness of high-fidelity patient simulation (HFPS) based on life-threatening clinical condition scenarios on undergraduate and postgraduate nursing students’ learning outcomes.DesignA systematic review and meta-analysis were conducted based on the Cochrane Handbook for Systematic Reviews of Interventions and its reporting was checked against the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist.Data sourcesPubMed, Scopus, CINAHL with Full Text, Wiley Online Library and Web of Science were searched until July 2017. Author contact, reference and citation lists were checked to obtain additional references.Study selectionTo be included, available full-texts had to be published in English, French, Spanish or Italian and (a) involved undergraduate or postgraduate nursing students performing HFPS based on life-threatening clinical condition scenarios, (b) contained control groups not tested on the HFPS before the intervention, (c) contained data measuring learning outcomes such as performance, knowledge, self-confidence, self-efficacy or satisfaction measured just after the simulation session and (d) reported data for meta-analytic synthesis.Review methodThree independent raters screened the retrieved studies using a coding protocol to extract data in accordance with inclusion criteria.Synthesis methodFor each study, outcome data were synthesised using meta-analytic procedures based on random-effect model and computing effect sizes by Cohen’s d with a 95% CI.ResultsThirty-three studies were included. HFPS sessions showed significantly larger effects sizes for knowledge (d=0.49, 95% CI [0.17 to 0.81]) and performance (d=0.50, 95% CI [0.19 to 0.81]) when compared with any other teaching method. Significant heterogeneity among studies was detected.ConclusionsCompared with other teaching methods, HFPS revealed higher effects sizes on nursing students’ knowledge and performance. Further studies are required to explore its effectiveness in improving nursing students’ competence and patient outcomes.