Background: Implementation of an intra-operative checklist has been associated with lower death rates and complications in a heterogeneous population. High-risk surgical patients may get the highest benefit from this measure. The aim of this study was to assess the efficiency of an intra-operative checklist in high-risk surgical patients living in a high-income country.
Methods: Design: prospective cohort study of pre- (I) and post-implementation (II + III) periods (II: immediate, III: 9 months after implementation); duration: 3 x 3 months. Inclusion criteria: >16 years, ASA >2. Exclusion: low risk surgery, obstetrical/gynaecologic surgery, vital surgery. Main outcomes: unplanned returns to operating theatre (OT), unplanned admissions to intensive care unit (ICU), death, and overall complications within 30 days. Changes in outcomes through checklist implementation were evaluated by calculating absolute risk reduction (ARR) and 95% confidence intervals (CI).
Results: 609 patients were included before and 1110 after implementation (552 in period II, 558 in III). Demographics were not statistically different between the groups (age, sex, BMI, ASA, surgery). Sixty-four percent had a completed checklist in II and 63% in III. No wrong patient or wrong site operation was observed during these periods.
Unplanned return to OT was observed in 45 patients (7.4%) before and in 67 (6.0%) after implementation (ARR 1.4% (95% CI -1.2; 3.9)). Return related to surgical site infection was found in 18 (3.0%) before and in 18 (1.6%) after implementation (ARR 1.3% (95% CI -0.2; 2.9)). Unplanned admission to ICU was observed in 17 (2.8%) before and in 31 (2.8%) after implementation (ARR 0 (95% CI -1.5; 1.7)). Main reason for unplanned readmission to ICU was respiratory failure (1.5% before and 1.1% after implementation; ARR 0.4 (95% CI -0.7; 1.5)). In-hospital death occurred in 26 (4.3%) before and in 68 (6.1%) after implementation (ARR -1.9% (95% CI -4.0; 0.3)).The number of overall complications was 81 (13.3%) before and 146 (13.2%) after implementation (ARR 0.2 (95% CI -3.2; 3.5)).
Conclusion: Implementation of the intra-operative checklist was not associated with significant effects in high-risk surgical patients when living in a highincome country. However, a trend towards decreased unplanned returns to operating theatre for surgical site infection was observed.