重大非心脏手术后病房持续生命体征监测以改善结局：一项随机临床试验
贵州医科大学 麻醉与心脏电生理课题组
翻译：周倩 编辑：周倩 审校：曹莹
尽管外科手术和围手术期护理已取得重大进展，但仍有三分之一患者在重大非心脏手术后出现并发症，且这些并发症往往由生命体征监测技术未能及时发现的异常所引发。通过实时警报的持续无线生命体征监测，有望有效降低生命体征异常和并发症的发生率。
方法
纳入接受大型非心脏手术的成年患者，并随机分为两组：一组接受标准护理（基于NEWS的手动间歇监测），另一组接受标准护理（基于NEWS的手动间歇监测）外加持续无线生命体征监测，后者在普通术后病房通过智能手机接收实时生命体征信息和警报。主要结局是每24小时严重生命体征偏差的累积持续时间（分钟），包括血氧饱和度下降、心动过速和心动过缓、呼吸过速和呼吸过缓、低血压和高血压。次要结局指标包括30天内的不良事件（AE）。患者和结局评估者均对随机分组不知情。
结果
400例患者被随机分组，干预组和对照组各200例。干预组和对照组严重生命体征异常持续时间的中位数[四分位间距(IQR)]分别为60[25-136]分钟/天和76[28-192]分钟/天，两组差异无统计学意义（p=0.19）。SpO2 < 88%的持续时间平均减少了47分钟/天（95% CI, 18-80；p = 0.02）。30天内，干预组和对照组的不良事件发生率分别为42.5%和31.5%（p = 0.02），严重不良事件发生率分别为34.5%和29.5%（p= 0.39）。
在本研究中，采用实时警报的持续生命体征监测并未显著降低严重生命体征异常的累积发生率。但血氧饱和度下降和不良事件的发生率显著降低，这为未来利用持续生命体征监测改善患者预后的研究提供了依据。
原始文献：Mølgaard J, Grønbæk KK, Rasmussen SS, et al. Continuous Vital Sign Monitoring at the Surgical Ward for Improved Outcomes After Major Noncardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2025 Oct 1;141(4):807-817. doi: 10.1213/ANE.0000000000007606. Epub 2025 Jul 1. PMID: 40591492; PMCID: PMC12410080.
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 Sp o2 <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.