Routine Postsurgical Anesthesia Visit to Improve 30-Day Morbidity and Mortality:A Multicenter, Stepped-Wedge Cluster Randomized Interventional Study (the TRACE Study)

OBJECTIVE: To study the impact of a standardized postoperative anesthesia visit on 30-day mortality in medium to high-risk elective surgical patients.BACKGROUND: Postoperative complications are the leading cause of perioperative morbidity and mortality. While modified early warning scores (MEWS) were instituted to monitor vital functions and improve postoperative outcome, we hypothesized that complementary anesthesia expertise is needed to adequately identify early deterioration.METHODS: In a prospective, multicenter, stepped-wedge cluster randomized interventional study in nine academic and non-academic hospitals in the Netherlands, we studied the impact of adding standardized postoperative anesthesia visits on day one and three to routine use of MEWS in 5473 patients undergoing elective non-cardiac surgery. Primary outcome was 30-day mortality. Secondary outcomes included: incidence of postoperative complications, length of hospital stay and intensive care unit (ICU) admission.RESULTS: Patients were enrolled between October 2016 and August 2018. Informed consent was obtained from 5473 patients of which 5190 were eligible for statistical analyses, 2490 in the control and 2700 in the intervention group. Thirty-day mortality was 0·56% (n = 14) in the control and 0·44% (n = 12) in the intervention group (odds ratio 0·74, 95%confidence interval 0·34-1·62). Incidence of postoperative complications did not differ between groups except for renal complications which was higher in the control group (1·7% (n = 41) vs. 1·0% (n = 27), p = 0·014). Median length of hospital stay did not differ significantly between groups. During the post-anesthesia visits, for 16% (n = 437) and 11% (n = 293) of patients recommendations were given on day one and three, respectively, of which 67% (n = 293) and 69% (n = 202) were followed up.CONCLUSIONS: The combination of MEWS and a postoperative anesthesia visit did not reduce 30-day mortality. Whether a postoperative anesthesia visit with strong adherence to the recommendations provided and in a high-risk population might have a stronger impact on postoperative mortality remains to be determined.TRIAL REGISTRATION: Netherlands Trial Registration, NTR5506/ NL5249, https://www.trialregister.nl/trial/5249.