外科病房的连续生命体征监测：COSMOS 试验。

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2024-11-11 DOI:10.1016/j.jclinane.2024.111661

Nikola Anusic MD , Alper Gulluoglu MD , Elyad Ekrami MD , Edward J. Mascha PhD , Shuyi Li MS , René Coffeng , Alparslan Turan MD , Amber Clemens BSN RN , Christine Perez RN , John W. Beard MD , Daniel I. Sessler MD

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引用次数: 0

摘要

研究目的：生命体征异常警报旨在识别有意义的患者不稳定性，同时限制警报疲劳。术后患者的最佳生命体征警报设置以及警报是否会导致有效的临床反应以减少生命体征紊乱仍是未知数。我们进行了一项分两个阶段的试点研究，以确定阈值和延迟，并检验连续监测发出的警报能缩短生命体征异常持续时间的假设：设计：两阶段试验：250名接受非心脏大手术的成人：干预措施所有患者均由护士每 4 小时进行一次常规生命体征监测。最初，我们连续记录了 100 名患者的饱和度、心率和呼吸频率，并由临床医生对其进行盲测。在第二阶段，我们将 150 名患者随机分组，分别接受盲法和非盲法连续生命体征监测。在非盲患者中，护士会对异常生命体征进行口头提醒：在第一阶段，我们利用 6082 小时的连续血氧饱和度、心率和呼吸频率数据对预期警报次数进行了建模。第二阶段选择了阈值和延迟，目标是每名患者每天发出 3 次警报。主要分析评估了非盲监测对生命体征异常累积持续时间的 5 个主要复合要素的影响。次要结果包括护士认为有意义的警报比例和临床干预次数：结果：在第一阶段，我们确定了平均每位患者每天发出 2.3 次警报的警报设置。在第二阶段，生命体征超过阈值的几何持续时间平均相对效应比为 0.75 [95 % CI: 0.51, 1.1]，P = 0.17。有 60 次警报（82%）在非盲法患者中被认为是有用的，从而使非盲法患者的干预次数增加了 60%：我们能够选择连续饱和度、心率和呼吸频率阈值，每天为每位患者发出约 2 次警报，护士认为几乎所有警报都有用。非盲监测和护理警报导致了干预措施（主要是增加供氧量），使生命体征异常非显著性地减少了 25%：NCT05280574。

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Continuous vital sign monitoring on surgical wards: The COSMOS pilot

Study objectives

Alerts for vital sign abnormalities seek to identify meaningful patient instability while limiting alarm fatigue. Optimal vital sign alarm settings for postoperative patients remain unknown, as is whether alerts lead to effective clinical responses reducing vital sign disturbances. We conducted a 2-phase pilot study to identify thresholds and delays and test the hypothesis that alerts from continuous monitoring reduce the duration of vital sign abnormalities.

Design

Two-phase pilot.

Patients

250 adults having major non-cardiac surgery.

Setting

Surgical wards.

Intervention

All patients had routine vital sign monitoring by nurses at 4-h intervals. We initially continuously recorded clinician-blinded saturation, heart rate, and respiratory rate in 100 patients. In the second phase, we randomized 150 patients to blinded versus unblinded continuous vital sign monitoring. In unblinded patients, nurses were verbally alerted to abnormal vital signs.

Measurements

In the first phase, we modeled expected alarm counts using 6082 h of continuous oxygen saturation, heart rate, and respiratory rate data. Thresholds and delays targeting ∼3 alarms per patient per day were selected for phase two. Primary analysis assessed the effect of unblinded monitoring across a 5-component primary composite of cumulative durations of vital sign abnormalities. Secondary outcomes included fraction of alerts deemed meaningful by nurses and number of clinical interventions.

Results

In phase one, we identified alarm settings that yielded an average of 2.3 alerts per patient per day. In phase two, the average relative effect ratio of geometric duration means for vital signs exceeding thresholds was 0.75 [95 % CI: 0.51, 1.1], P = 0.17. Sixty alarms (82 %) were deemed useful in unblinded patients, leading to 60 % more interventions in unblinded patients.

Conclusions

We were able to select continuous saturation, heart rate, and respiratory rate thresholds that generated about 2 alerts per patient per day, nearly all of which were considered useful by nurses. Unblinded monitoring and nursing alerts led to interventions (mostly increasing oxygen delivery) that non-significantly reduced vital sign abnormalities by 25 %.

ClinicalTrials.gov registration: NCT05280574.

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来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.