Department of Anaesthesia & Critical Care, Postgraduate Institute of Medical Education & Research, Chandigarh, India.
Nehru Hospital, Postgraduate Institute of Medical Education & Research, , Anaesthesia Office 4th Floor, Chandigarh, 160012, India.
J Clin Monit Comput. 2022 Dec;36(6):1657-1665. doi: 10.1007/s10877-022-00810-8. Epub 2022 May 19.
Closed-loop systems have been designed to assist anesthetists in controlling anesthetic drugs and also maintaining the stability of various physiological variables in the normal range. In the present study, we describe and clinically evaluated a novel closed-loop automated blood pressure control system (CLAPS) in patients undergoing cardiac surgery under cardiopulmonary bypass. Forty ASA II-IV adult patients undergoing elective cardiac surgery were randomly allocated to receive adrenaline, noradrenaline, phenylephrine and nitroglycerine (NTG) adjusted either through CLAPS (CLAPS group) or manually (Manual group). The desired target mean arterial blood pressure (MAP) for each patient in both groups was set by the attending anesthesiologist. The hemodynamic performance was assessed based on the percentage duration of time the MAP remained within 20% of the set target. Automated controller performances were compared using performance error criteria of Varvel (MDPE, MDAPE, Wobble) and Global Score. MAP was maintained a significantly longer proportion of time within 20% of the target in the CLAPS group (79.4% vs. 65.5% p < 0.001, 't' test) as compared to the manual group. Median absolute performance error, wobble, and Global score was significantly lower in the CLAPS group. Hemodynamic stability was achieved with a significantly lower dose of Phenyepherine in the CLAPS group (1870 μg vs. 5400 μg, p < 0.05, 't' test). The dose of NTG was significantly higher in the CLAPS group (3070 μg vs. 1600 μg, p-value < 0.05, 't' test). The cardiac index and left ventricular end-diastolic area were comparable between the groups. Automated infusion of vasoactive drugs using CLAPS is feasible and also better than manual control for controlling hemodynamics during cardiac surgery. Trial registration number and date This trial was registered in the Clinical Trial Registry of India under Registration Number CTRI/2018/01/011487 (Retrospective; registration date; January 23, 2018).
闭环系统旨在协助麻醉师控制麻醉药物，并维持心肺旁路手术患者的各种生理变量在正常范围内的稳定。在本研究中，我们描述并临床评估了一种新型的闭环自动血压控制系统（CLAPS）在体外循环下心内直视手术患者中的应用。40 例 ASA II-IV 级择期心内直视手术患者随机分为肾上腺素、去甲肾上腺素、苯肾上腺素和硝化甘油（NTG）调整通过 CLAPS（CLAPS 组）或手动（手动组）。两组患者的目标平均动脉压（MAP）由主治麻醉师设定。根据 MAP 持续时间百分比来评估血流动力学性能，MAP 维持在设定目标的 20%以内。使用 Varvel（MDPE、MDAPE、Wobble）和总评分的性能误差标准比较自动控制器的性能。与手动组相比，CLAPS 组 MAP 维持在设定目标的 20%以内的时间比例显著更长（79.4%比 65.5%，p<0.001，t 检验）。CLAPS 组的中位数绝对性能误差、摆动和总评分显著较低。CLAPS 组苯肾上腺素的剂量明显较低（1870μg 比 5400μg，p<0.05，t 检验）。CLAPS 组 NTG 的剂量明显较高（3070μg 比 1600μg，p 值<0.05，t 检验）。两组的心脏指数和左心室舒张末期面积无差异。使用 CLAPS 自动输注血管活性药物是可行的，并且在心脏手术期间控制血液动力学方面优于手动控制。 试验注册号和日期 该试验在印度临床试验注册处注册，注册号为 CTRI/2018/01/011487（回顾性；注册日期；2018 年 1 月 23 日）。
