Continuous Vital Sign Monitoring at the Surgical Ward for Improved Outcomes After Major Noncardiac Surgery: A Randomized Clinical Trial.

Abstract

BACKGROUND Complications occur in a third of patients after major noncardiac surgery and are often preceded by vital sign deviations undetected by current vital sign monitoring practice, despite major advances in surgical and perioperative care. Continuous wireless vital sign monitoring with real-time alerts may allow for a reduction of vital sign abnormalities and complications. METHODS Adult patients undergoing major noncardiac surgery were included and randomized to either standard of care (manual intermittent vital sign monitoring) vs standard of care plus continuous wireless vital sign monitoring with real-time vital sign alerts to staff smartphones at the general postoperative ward. The primary outcome was cumulative duration of severe vital sign deviations, including desaturation, tachy- and bradycardia, tachy- and bradypnea, hypo- and hypertension. Secondary outcomes included adverse events within 30 days. Patients and outcome assessors were blinded to the randomization. RESULTS Four hundred patients were randomized, with 200 in the intervention and 200 in the control group, respectively. Median [interquartile range (IQR)] duration of severely deviating vital signs was 60 [25-136] vs 76 [28-192] min/d in the intervention versus control group, respectively (P = .19). Duration of Spo2 <88% had a mean reduction of 47 minutes per day (95% confidence interval [CI], 18-80, P = .02). Adverse events occurred in 42.5% vs 31.5% of patients within 30 days (P = .02), and serious adverse events in 34.5% vs 29.5% (P = .39). CONCLUSIONS Continuous vital sign monitoring with real-time staff alerts did not significantly reduce cumulative severe vital sign deviations in this setup. Significant reductions in desaturations and adverse events were found, giving evidence to future studies in the use of continuous vital sign monitoring to improve patient outcomes.