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Comparison of manual and automated respiratory rate measurements on hospital wards: a prospective observational study. 医院病房手动和自动呼吸频率测量的比较:一项前瞻性观察研究。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-11-15 DOI: 10.1007/s10877-025-01380-1
Sherif Gonem, Lucy Stones, Donna Ward, Steve Briggs, Tricia McKeever

Respiratory rate is an important early sign of clinical deterioration but the current practice of counting breaths manually is time-consuming and prone to error. We aimed to determine the concordance between manual respiratory rate measurements and automated measurements recorded using a wearable device. We undertook a prospective observational study on three general respiratory wards to compare manual respiratory rate measurements collected during usual clinical care with automated readings from a wearable respiratory rate monitor (RespiraSense, PMD Solutions, Cork, Ireland). Thirty-one patients took part in the study. Manual respiratory rate readings displayed large peaks at 20 and 24 breaths/min, whereas automated readings followed a smooth bell-shaped distribution. Manual and automated respiratory rates were both higher during the day than at night, and this was more marked for automated readings. Automated readings were on average 2.5 (95% confidence interval [CI] 2.2 to 2.8) breaths/minute higher than time-matched manual readings, and the 95% limits of agreement were - 7.9 (95% CI -8.4 to -7.4) and 12.9 (95% CI 12.3 to 13.4) breaths/minute, wider than the clinically acceptable limits of ± 3 breaths/min. Trends in manual and automated respiratory rates were concordant in only 56% of cases. Automated respiratory rate measurements using RespiraSense do not display clinically acceptable agreement with manual measurements in the setting of a respiratory ward.

呼吸频率是临床恶化的重要早期标志,但目前人工计数呼吸的做法既耗时又容易出错。我们的目的是确定手动呼吸频率测量和使用可穿戴设备记录的自动测量之间的一致性。我们在三个普通呼吸病房进行了一项前瞻性观察研究,以比较在常规临床护理期间收集的人工呼吸率测量值与可穿戴呼吸率监测器(呼吸器,PMD解决方案,爱尔兰科克)的自动读数。31名患者参加了这项研究。手动呼吸频率读数在20和24次呼吸/分钟时显示出较大的峰值,而自动读数遵循平滑的钟形分布。手动和自动呼吸频率在白天都比晚上高,这一点在自动读数中更为明显。自动读数平均比时间匹配的手动读数高2.5(95%置信区间[CI] 2.2至2.8)次/分钟,95%一致性限为- 7.9 (95% CI -8.4至-7.4)和12.9 (95% CI 12.3至13.4)次/分钟,比临床可接受的±3次/分钟的限宽。手动呼吸频率和自动呼吸频率的趋势只有56%是一致的。在呼吸病房的设置中,使用呼吸器的自动呼吸频率测量与手动测量不显示临床可接受的一致性。
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引用次数: 0
Comparing pulse oximeter performance using a common functional tester versus controlled desaturation studies on healthy participants. 比较使用普通功能测试仪的脉搏血氧仪性能与健康参与者的控制去饱和研究。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-11-14 DOI: 10.1007/s10877-025-01381-0
Seif Elmankabadi, Jake Dove, Ella Behnke, Yu Celine Chou, Lily Ortiz, Gregory Leeb, Isabella Auchus, Danni Chen, John Feiner, Tyler J Law, Philip E Bickler, Shamsudini Hashi, René Vargas Zamora, Fekir Negussie, Ronald Bisegerwa, Michael Bernstein, Michael S Lipnick

Functional testers are designed to evaluate select pulse oximeter characteristics but are often misused to validate device accuracy, potentially providing false reassurance. This study evaluated whether the Fluke ProSim8 (FPS8) could accurately predict oximeter performance during human controlled desaturation studies or identify performance differences under low signal conditions. 12 oximeters were tested using two FPS8 protocols: (1) an 'SpO₂ plateau' protocol which mimicked controlled desaturation studies by evaluating device performance over a range of simulated SpO2 (70-100%), and (2) a 'signal space' protocol designed to assess device accuracy under varying modulation and transmission conditions. Each device also underwent controlled desaturation testing in healthy adults. Six of the 12 oximeters passed (ARMS ≤ 3%) the SpO₂ plateau protocol; however, three of these failed (ARMS > 3%) human testing. At lower simulated saturations, most devices overestimated SpO₂. In the signal space protocol, oximeters performed well under high signal conditions, but many failed to produce readings or showed SpO₂ errors > 3% under low signal conditions. On average, oximeters failed to generate a reading 20.2 ± 7.2 times out of 60 attempts. Ten devices passed (ARMS < 3%) the signal space protocol, but two of these failed human testing. Oximeter performance on the FPS8 did not correlate with human performance (R² = 0.08 for the plateau protocol; R² = 0.01 for the signal space protocol). The FPS8 did not reliably predict oximeter accuracy in human desaturation studies or under low signal conditions; current functional tester protocols are limited in predicting real-world oximeter performance.

功能测试仪设计用于评估选定的脉搏血氧仪特性,但经常被误用来验证设备的准确性,可能提供错误的保证。本研究评估Fluke ProSim8 (FPS8)是否能准确预测人体控制去饱和度研究中血氧仪的性能,或识别低信号条件下的性能差异。12个血氧仪使用两种FPS8协议进行测试:(1)“SpO2平台”协议,通过评估设备在模拟SpO2(70-100%)范围内的性能来模拟受控去饱和度研究;(2)“信号空间”协议,旨在评估设备在不同调制和传输条件下的准确性。每个装置还在健康成人中进行了控制去饱和测试。12个血氧仪中有6个通过了SpO 2平台方案(ARMS≤3%);然而,其中三种药物在人体试验中失败(ARMS > %)。在较低的模拟饱和度下,大多数设备高估了SpO₂。在信号空间协议中,血氧仪在高信号条件下表现良好,但在低信号条件下,许多血氧仪无法产生读数或显示SpO 2误差>.3 %。平均而言,在60次尝试中,血氧计未能产生20.2±7.2次读数。10台设备通过ARMS测试
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引用次数: 0
Comparison of the change in carotid corrected flow time and stroke volume variation for assessing volume responsiveness in general anesthesia patients: a prospective, observational study. 评估全身麻醉患者容量反应性的颈动脉校正血流时间和脑卒中容量变化的比较:一项前瞻性观察性研究。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-29 DOI: 10.1007/s10877-025-01375-y
Yongyong Yang, Min Li, Chenlong Yang, Zhongmou Shi, Huanghui Wu, Guozhong Chen, Lu Chen

Background: Accurately identifying surgical patients who will have an increase in stroke volume following fluid administration remains challenging when utilizing noninvasive bedside methods. This study aims to compare the value of using ultrasound to measure changes in corrected carotid artery flow time (ΔFTc) with that of using invasive measurements of stroke volume variation (ΔSVV) for assessing volume responsiveness in patients under general anesthesia and mechanical ventilation.

Methods: A total of 91 patients undergoing elective abdominal surgery under general anesthesia were enrolled in this prospective observational study. Under general anesthesia and mechanical ventilation, the ΔFTc was measured using noninvasive bedside ultrasound, and the ΔSVV was measured using invasive hemodynamic monitoring, both before and after fluid administration. Fluid responders were defined as an increase in stroke volume of ≥ 10% after the fluid challenge.

Results: A total of 47 (54.0%) patients were fluid responders. The ΔFTc was 14.5 ± 8.3 ms for responders and 5.7 ± 4.9 ms for non-responders, while the ΔSVV was 3.3 ± 1.4% for responders and 1.7 ± 0.7% for non-responders. The areas under the receiver operating characteristic curves for ΔFTc and ΔSVV were 0.85 (95% CI 0.77-0.92; P < 0.05) and 0.84 (95% CI 0.75-0.93; P < 0.05), respectively. The optimal cutoff values were 7.03 ms for ΔFTc (sensitivity 91.5%, specificity 69.8%) and 2.85% for ΔSVV (sensitivity 95.6%, specificity 72.6%). A narrower gray zone for ΔFTc, ranging from 7 ms to 12 ms and covering 27 patients, was observed compared with that for ΔSVV, which ranged from 1% to 3% and covered 41 patients.

Conclusions: Both the ΔFTc and ΔSVV reliably assessed fluid responsiveness in patients undergoing general anesthesia and mechanical ventilation. Noninvasive bedside ultrasound measurement of ΔFTc can serve as an accurate assessment parameter, reflecting the presence of volume responsiveness following rapid fluid administration and showing greater clinical applicability.

Trial registration: www.chictr.org.cn (ChiCTR2500101114); registered 21 April 2025.

背景:当使用无创床边方法时,准确识别输液后卒中容量增加的手术患者仍然具有挑战性。本研究旨在比较超声测量校正后颈动脉血流时间变化(ΔFTc)与有创测量脑卒中容量变化(ΔSVV)在评估全麻和机械通气患者容量反应性方面的价值。方法:本前瞻性观察研究共纳入91例全麻下择期腹部手术患者。在全麻和机械通气条件下,采用无创床边超声测量ΔFTc,采用有创血流动力学监测ΔSVV。液体反应者定义为在液体刺激后,脑冲量增加≥10%。结果:47例(54.0%)患者有液体反应。应答者ΔFTc为14.5±8.3 ms,无应答者为5.7±4.9 ms,应答者ΔSVV为3.3±1.4%,无应答者ΔSVV为1.7±0.7%。ΔFTc和ΔSVV的受试者工作特征曲线下面积为0.85 (95% CI 0.77-0.92; P)结论:ΔFTc和ΔSVV可靠地评估了全麻和机械通气患者的液体反应性。无创床边超声测量ΔFTc可作为准确的评估参数,反映快速给液后是否存在体积反应性,具有更大的临床适用性。试验注册:www.chictr.org.cn (ChiCTR2500101114);注册于2025年4月21日。
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引用次数: 0
Exploring sevoflurane consumption and CO2 emissions of individual patients undergoing noncardiac surgery using a target-controlled sevoflurane administration system. 利用靶控七氟烷给药系统探讨非心脏手术患者个体七氟烷消耗和CO2排放。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-21 DOI: 10.1007/s10877-025-01370-3
Yann Gricourt, Guillaume Bibollet, Mikael Perin, Pierre-Baptiste Vialatte, Patrice Forget, Brenton Alexander, Virginie Chasseigne, Jean-Yves Lefrant, Myriam Mezzarobba, Philippe Cuvillon

Reduce sevoflurane consumption during anaesthesia remains an economic and environmental challenge. This case study analyzed retrospectively a large cohort of procedures using end-tidal (ET) Control to optimize sevoflurane consumption and assess the impact of ventilator settings on it. In single center, consecutive adult procedures for noncardiac surgery under general anaesthesia were analyzed in twelve operating rooms. The anaesthesia system (Aisys CS2, GE, USA) was connected to software (Carestation Insight, GE, USA) that automatically recorded sevoflurane consumption for each case. Left to the discretion of the anaesthesiologist, fresh gas flow (FGF) was set at 0.5, 0.8 or 1 L.min-1 with an initial end-tidal sevoflurane target of 1.2-2% to reach the goal of approximately 1.0 MAC. The primary endpoint was the sevoflurane consumption (mL.min-1). Secondary endpoints were sevoflurane consumption and carbon footprint for the cohort (sevoflurane GWP20 = 702) and by anaesthesia duration, type of airway management (endotracheal intubation EI, laryngeal mask LM), FGF and initial sevoflurane settings. From May to September 2024, 3064 procedures were recorded via the app. with a median (IQR) duration of surgery of 79 (47-124) minutes. Sevoflurane consumption was. 19 528 mL. Median (IQR) sevoflurane consumption was 0.16 (0.12-0.20) mL.min-1 with a carbon footprint (sevoflurane GWP20 including manufacturing = 1,468 kg/mL) of 0,23(0.17-0.29) kgCO2eq.min-1.Subgroup analysis demonstrated that FGF at 0.8 or 1.0 L.min-1 significantly increased sevoflurane consumption and CO2 emission when compared with 0.5 L.min-1 (P < 0.01). Initial ET target sevoflurane levels of 1.2% vs greater than 1.2% did not change total sevoflurane consumption. Regarding airway management (EI vs LM), LM use was associated with higher consumption, specifically when duration > 120 min (P < 0.01). In this large cohort of cases, this study demonstrated that controlling ET with an FGF target of 0.5 L.min-1 remained the best way to reduce sevoflurane consumption. Other settings did not significantly reduce gas consumption.

减少麻醉期间七氟醚的消耗仍然是一项经济和环境挑战。本病例研究回顾性分析了大量使用末潮(ET)控制来优化七氟烷消耗的程序,并评估了呼吸机设置对其的影响。在单中心研究中,我们分析了在全身麻醉下连续进行成人非心脏手术的12间手术室。麻醉系统(Aisys CS2, GE, USA)连接到软件(Carestation Insight, GE, USA),该软件自动记录每个病例的七氟醚用量。由麻醉师自行决定,将新鲜气体流量(FGF)设定为0.5、0.8或1 L.min-1,初始末七氟烷目标为1.2-2%,以达到约1.0 MAC的目标。主要终点是七氟烷消耗(mL.min-1)。次要终点是该队列的七氟烷消耗量和碳足迹(七氟烷GWP20 = 702),以及麻醉时间、气道管理类型(气管插管EI、喉罩LM)、FGF和七氟烷初始设置。从2024年5月到9月,通过应用程序记录了3064例手术,手术中位(IQR)持续时间为79(47-124)分钟。七氟烷的消耗量是。中位数(IQR)七氟烷消耗量为0.16 (0.12-0.20)mL.min-1,碳足迹(七氟烷GWP20包括制造= 1,468 kg/mL)为0,23(0.17-0.29)kgCO2eq.min-1。亚组分析表明,与0.5 L.min-1相比,0.8或1.0 L.min-1的FGF显著增加了七氟烷消耗和二氧化碳排放(P 120 min (P -1)仍然是减少七氟烷消耗的最佳方式)。其他设置并没有显著降低油耗。
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引用次数: 0
Fluid management methods for severely burned patients: a narrative review. 严重烧伤患者的液体管理方法:叙述性回顾。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-16 DOI: 10.1007/s10877-025-01365-0
Yi Yao, Tianzhen Hua, Yucong Li, Meiqing Zhang, Wei Liu

Burn shock is a major early complication in the treatment of severely burned patients, and precise and timely fluid management is essential for survival. Traditional clinical indicators such as urine output, blood pressure, central venous pressure (CVP), and blood lactate are commonly used, but each has significant limitations. Invasive hemodynamic monitoring technologies, such as Pulmonary Artery Catheterization (PAC) and Pulse Contour Cardiac Output (PiCCO), have improved the accuracy of fluid assessment, but carry risks of infection and procedural complications and require experienced clinical interpretation within the context of the patient's overall condition. Non-invasive ultrasound-based methods, including critical care ultrasonography and the Venous Excess Ultrasound Score (VExUS), are emerging as promising alternatives, particularly in resource-limited settings. This review summarizes current methods for fluid management in severely burned patients, with a focus on the concepts of fluid responsiveness and fluid tolerance, and provides recommendations for clinical practice.

烧伤休克是严重烧伤患者治疗的主要早期并发症,准确及时的输液管理对生存至关重要。传统的临床指标如尿量、血压、中心静脉压(CVP)、血乳酸等是常用的指标,但各指标都有明显的局限性。有创血流动力学监测技术,如肺动脉导管(PAC)和脉搏轮廓心输出量(PiCCO),提高了液体评估的准确性,但存在感染和手术并发症的风险,需要有经验的临床医生根据患者的整体情况进行解释。基于非侵入性超声的方法,包括重症监护超声检查和静脉超声评分(VExUS),正在成为有希望的替代方法,特别是在资源有限的情况下。本文综述了目前严重烧伤患者的液体管理方法,重点介绍了液体反应性和液体耐受性的概念,并为临床实践提供了建议。
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引用次数: 0
Enhancing tidal volume estimation from electrical impedance tomography (EIT) by applying human anthropometric information. 应用人体测量信息增强电阻抗层析成像(EIT)潮汐体积估算。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-15 DOI: 10.1007/s10877-025-01367-y
Amelie Zitzmann, Anna Strübing, Daniel A Reuter, Andreas Waldmann, Stephan H Böhm, Fabian Müller-Graf

Purpose: Electrical impedance tomography (EIT) is a functional imaging technique to monitor regional ventilation. However, the quantification of clinically used ventilation parameters like tidal volume (VT) has not been possible yet since EIT measures relative and not absolute changes in impedance. Thus, the study aimed to evaluate the relationship between impedance changes (dZ) and VT in humans and to identify influencing factors.

Methods: 27 patients undergoing elective surgery under general anaesthesia were equipped with a commercially available EIT belt. Measurements were performed at four VTs (6, 8, 10 and 12 mL/BW) on each of four PEEP levels (0, 5, 10 and 15 cmH2O). Linear regression analysis was performed for normalized dZ and VT per ideal bodyweight (VT_IBW). Additionally, PEEP, gender, age, height and weight were analysed as potential influencing factors.

Results: Regression analysis for individual patients showed good correlations between VT_IBW and normalized dZ (mean R2 0.890 ± 0.15). However, for the group of patients, correlations were rather weak (R2 0.485). Including additional factors improved the model (adjusted R2 0.767), with VT_IBW having the biggest impact, followed by weight, height and PEEP; age did not contribute to it significantly. Higher VT_IBW, PEEP and height increased, while female gender and higher weight decreased normalized dZ.

Conclusion: Normalized dZ correlated strongly with VT_IBW in the individual ventilated humans but more weakly when analyzing the cohort. PEEP, gender, weight and height were identified as additional influencing factors.

Trial registration: This study was prospectively registered at the German Register of Clinical Studies (Deutsches Register Klinischer Studien; DRKS00027226) on 3rd December 2021.

目的:电阻抗断层扫描(EIT)是一种监测局部通气的功能成像技术。然而,由于EIT测量的是阻抗的相对变化而不是绝对变化,因此尚无法量化临床使用的通气参数,如潮气量(VT)。因此,本研究旨在评估人体阻抗变化(dZ)与VT之间的关系,并确定影响因素。方法:27例在全麻下择期手术的患者配备市售EIT带。在四个PEEP水平(0、5、10和15 cmH2O)上分别以4个vtt(6、8、10和12 mL/BW)进行测量。对归一化dZ和VT /理想体重(VT_IBW)进行线性回归分析。此外,还分析了PEEP、性别、年龄、身高、体重等可能的影响因素。结果:个体回归分析显示VT_IBW与归一化dZ具有良好的相关性(平均R2 0.890±0.15)。然而,对于患者组,相关性相当弱(R2 0.485)。纳入其他因素后,模型得到改善(调整后R2为0.767),其中VT_IBW的影响最大,其次是体重、身高和PEEP;年龄对其影响不显著。较高的VT_IBW、PEEP和身高增加,而女性和较高的体重降低了归一化dZ。结论:归一化dZ与通气个体VT_IBW相关性较强,但在队列分析中相关性较弱。PEEP、性别、体重和身高是其他影响因素。试验注册:该研究于2021年12月3日在德国临床研究注册中心(Deutsches Register Klinischer studen; DRKS00027226)前瞻性注册。
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引用次数: 0
Protective mechanical ventilation controlled by the real-time mechanical power measurement. 防护机械通风通过实时机械功率测量控制。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-11 DOI: 10.1007/s10877-025-01369-w
Filip Burša, Michal Frelich, Peter Sklienka, Zuzana Kučerová, Jiří Sagan, David Oczka, Marek Penhaker, Michal Burda, Jan Máca

Background: Despite the substantial advancements in mechanical ventilation (MV), mortality remains high. Mechanical power (MP), MV forces are associated with outcomes. Real-time monitoring of MP and the adjustment of MV according to MP may result in ventilation with lower MP.

Methods: Randomized controled trial conducted at the ECMO Centre Ostrava, Czech Republic, from March 2023 to March 2024 enrolled adult patients on MV (with or without extracorporeal membrane oxygenation, ECMO) with acute respiratory failure. A system for real-time MP monitoring (geometric method and simplified Becher´s formula) has been developed. In the intervention arm, the physician was able to observe the MP in real time and adjust the MV parameters accordingly. In the control group, the MP was concealed.

Results: A total of 494 subjects were screened and 33 patients were randomized (further 7 ECMO patients). There was no significant difference between the control and intervention groups. Median MPGeom was 3.22 J/min (maximum 15.2 J/min) and MPBecher of 5.94 J/min (maximum 18.4 J/min). Only a weak (but significant, p = 0.0001) correlation between MPGeom and MPBecher was observed. A highly significant difference was observed in MP between day and night (6 a.m. - 6 p.m.) with higher MP at night.

Conclusion: Although real-time MP measurement is feasible, there was no significant difference in MP between the control and intervention groups with low MP in both groups. Experience physicians was capable of safe MV, even if they do not know the exact MP value. The night shift was a high-risk period for developing lung damage due to elevated MP.

Trial registration: ClinicalTrials NCT06035146.

背景:尽管机械通气(MV)有了长足的进步,但死亡率仍然很高。机械功率(MP)、中压力与结果相关。实时监测MP并根据MP调整MV可导致低MP通气。方法:随机对照试验于2023年3月至2024年3月在捷克共和国奥斯特拉发ECMO中心进行,纳入急性呼吸衰竭的成年患者(有或没有体外膜氧合,ECMO)。开发了一种基于几何法和简化贝歇公式的实时MP监测系统。在干预组,医生能够实时观察血压,并相应地调整血压参数。在对照组中,MP被隐藏。结果:共筛选494例受试者,随机抽取33例患者(另有7例ECMO患者)。对照组和干预组之间无显著差异。中位MPGeom为3.22 J/min(最大15.2 J/min), MPBecher为5.94 J/min(最大18.4 J/min)。MPGeom和MPBecher之间只有微弱(但显著,p = 0.0001)的相关性。在白天和晚上(早上6点至下午6点)观察到MP的高度显著差异,夜间MP较高。结论:虽然实时测量MP是可行的,但对照组和干预组之间的MP无显著差异,两组MP均较低。经验丰富的医生即使不知道确切的MP值,也能安全的进行MV测量。夜班是MP升高导致肺损伤的高危期。试验注册:ClinicalTrials NCT06035146。
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引用次数: 0
Reply to the comment on the article: Reduction of the acquisition time needed to obtain somatosensory evoked potentials by estimation of the required averaging sweep count by an algorithm. 回复文章评论:通过算法估计所需的平均扫描计数来减少获得体感诱发电位所需的获取时间。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-09 DOI: 10.1007/s10877-025-01368-x
Clemens Bothe
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引用次数: 0
Opioid administration guided by Surgical Pleth Index in patients with a combination of general and regional anaesthesia during trauma and orthopaedic surgery: a double-blind, randomised controlled trial. 创伤和骨科手术中全麻和局部麻醉联合使用的阿片类药物:一项双盲、随机对照试验。
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-03 DOI: 10.1007/s10877-025-01363-2
Kim C Koschmieder, Hans O Pinnschmidt, Lea-Sophie Borst, Gillis Greiwe, Elena Kainz, Marlene Fischer, Rainer Nitzschke

Purpose: This randomised controlled trial investigated the effect of Surgical Pleth Index (SPI) guided sufentanil administration on intraoperative sufentanil consumption compared to routine care in patients with a combination of general anaesthesia and regional anaesthesia having trauma and orthopaedic surgery.

Methods: Eighty patients with a combination of general anaesthesia and regional anaesthesia undergoing trauma or orthopaedic surgery were randomised into two groups to receive either sufentanil guided by SPI monitoring or by routine care (Control). The primary endpoint was intraoperative sufentanil consumption. Secondary endpoints were postoperative pain level, opioid consumption, incidence of nausea, duration of time in the post-anaesthesia care unit (PACU) and quality of recovery.

Results: The median intraoperative sufentanil administration adjusted to bodyweight and surgery duration did not differ between the groups: SPI guided group 2.29 (interquartile range, IQR 0.29 to 6.91), Control 1.65 (IQR 0.83 to 2.63) µg·kg-1·min-1*1000 (P = 0.906). The relative risk for receiving intraoperative sufentanil was RR 0.909 (95% CI 0.723 to  1.143, P = 0.414). Median morphine equivalents administered in the 24 h after discharge from the PACU were 3.8 (IQR 0.0 to 22.5) in the SPI guided group and 19.1 (IQR 3.8 to 30.0) mg (P = 0.021) in the control group without adjustment for multiple testing. Other secondary endpoints showed no differences.

Conclusion: SPI guided sufentanil administration did not reduce intraoperative sufentanil consumption compared to routine care in patients having trauma and orthopaedic surgery with a combination of general anaesthesia and regional anaesthesia.

Trial registration: Clinicaltrials.gov identifier NCT06040307 (registered September 8, 2023).

目的:本随机对照试验调查外科手术体积指数(SPI)指导舒芬太尼给药对术中舒芬太尼用量的影响,与常规护理相比,在创伤和骨科手术中全麻和区域麻醉联合使用的患者。方法:80例创伤或骨科手术全麻和区域麻醉联合应用的患者随机分为两组,在SPI监测指导下接受舒芬太尼治疗和常规护理(对照组)。主要终点是术中舒芬太尼的消耗。次要终点是术后疼痛水平、阿片类药物消耗、恶心发生率、麻醉后护理单位(PACU)的持续时间和恢复质量。结果:术中舒芬太尼给药中位数与体重和手术时间的关系各组间无显著差异:SPI引导组2.29(四分位数范围,IQR 0.29 ~ 6.91),对照组1.65 (IQR 0.83 ~ 2.63)µg·kg-1·min-1*1000 (P = 0.906)。术中使用舒芬太尼的相对危险度RR为0.909 (95% CI 0.723 ~ 1.143, P = 0.414)。SPI引导组出院后24 h吗啡当量中位数为3.8 mg (IQR为0.0 ~ 22.5),对照组为19.1 mg (IQR为3.8 ~ 30.0)mg (P = 0.021)。其他次要终点无差异。结论:与常规护理相比,SPI引导舒芬太尼给药并没有减少创伤骨科手术患者术中舒芬太尼的消耗,同时采用全身麻醉和区域麻醉。试验注册:Clinicaltrials.gov识别码NCT06040307(注册于2023年9月8日)。
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引用次数: 0
Cost-effectiveness of data driven personalised antibiotic dosing in critically ill patients with sepsis or septic shock. 数据驱动的个体化抗生素给药对脓毒症或感染性休克危重患者的成本效益
IF 2.2 3区 医学 Q2 ANESTHESIOLOGY Pub Date : 2025-10-01 Epub Date: 2025-01-24 DOI: 10.1007/s10877-024-01257-9
Hana M Broulikova, Jacqueline Wallage, Luca Roggeveen, Lucas Fleuren, Tingjie Guo, Paul W G Elbers, Judith E Bosmans

Purpose: This study provides an economic evaluation of bedside, data-driven, and model-informed precision dosing of antibiotics in comparison with usual care among critically ill patients with sepsis or septic shock.

Methods: This economic evaluation was conducted alongside an AutoKinetics randomized controlled trial. Effect measures included quality-adjusted life years (QALYs), mortality and pharmacokinetic target attainment. Costs were measured from a societal perspective. Missing data was multiply imputed, and bootstrapping was used to estimate statistical uncertainty. Differences in effects and costs were estimated using bivariate regression and used to calculate incremental cost-effectiveness ratios.

Results: Patients in the intervention group had higher costs (€42,684 vs. 39,475), lower mortality (42% vs. 49%), more QALYs (0.184 vs. 0.153), and higher pharmacokinetic target attainment (69% vs. 48%). Only the difference for target attainment was found statistically significant. An additional €18,129, €55,576, and €123,493 needs to be invested to attain the targeted plasma levels for one more patient, to save one life and gain one QALY, respectively. The probability of cost-effectiveness for all effect outcomes is below 60% for most acceptable willingness-to-pay thresholds.

Conclusions: Data-driven personalised antibiotic dosing in critically ill patients as implemented in the AutoKinetics trial cannot be recommended for implementation as a cost-effective intervention.

Trial registration: The trial was prospectively registered at Netherlands Trial Register (NTR), NL6501/NTR6689 on 25 August 2017 and at the European Clinical Trials Database (EudraCT), 2017-002478-37 on 6 November 2017.

目的:本研究对重症脓毒症或感染性休克患者的床边、数据驱动和模型知情的抗生素精确剂量进行了经济评估,并与常规护理进行了比较。方法:该经济评价与AutoKinetics随机对照试验同时进行。效果测量包括质量调整生命年(QALYs)、死亡率和药代动力学目标实现情况。成本是从社会角度来衡量的。对缺失数据进行多重输入,并用自举法估计统计不确定性。使用双变量回归估计效果和成本的差异,并用于计算增量成本-效果比。结果:干预组患者费用较高(42,684欧元对39,475欧元),死亡率较低(42%对49%),QALYs较高(0.184对0.153),药代动力学目标达到率较高(69%对48%)。只有达到目标的差异在统计学上是显著的。另外需要投入18,129欧元、55,576欧元和123,493欧元,以使每增加一名患者达到目标血浆水平、挽救一条生命和获得一个QALY。对于大多数可接受的支付意愿阈值,所有效果结果的成本效益概率低于60%。结论:在AutoKinetics试验中实施的数据驱动的危重患者个性化抗生素剂量不能作为一种具有成本效益的干预措施推荐实施。试验注册:该试验于2017年8月25日在荷兰试验注册中心(NTR) NL6501/NTR6689前瞻性注册,并于2017年11月6日在欧洲临床试验数据库(EudraCT) 2017-002478-37前瞻性注册。
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Journal of Clinical Monitoring and Computing
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