End-Tidal Control Versus Manual Control of Inhalational Anesthesia Delivery: A Randomized Controlled Noninferiority Trial.

IF 4.6 2区 医学 Q1 ANESTHESIOLOGY Anesthesia and analgesia Pub Date : 2024-10-01 Epub Date: 2024-07-19 DOI:10.1213/ANE.0000000000007132
Melissa D McCabe, Guy de L Dear, Matthew A Klopman, Kritika Garg, Melinda S Seering
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Abstract

Background: Precise anesthesia delivery helps ensure amnesia, analgesia, and immobility. Conventionally, the end-tidal anesthetic concentration is maintained through manual adjustment of the fresh gas flow and anesthetic vaporizer output. Some anesthesia delivery systems can deliver and maintain clinician-selected end-tidal anesthetic agent (EtAA) concentration using a modified closed-loop system. We evaluated the performance of an End-tidal Control (EtC) system on the Aisys CS 2 anesthesia machine (GE HealthCare). We hypothesized EtC anesthetic delivery would be noninferior to manually controlled anesthetic delivery.

Methods: The Multi-site Anesthesia randomized controlled STudy of End-tidal control compared to conventional Results (MASTER) Trial evaluated anesthetic delivery in 210 adult patients receiving inhaled anesthesia. Patients were randomized to either EtC or manual control (MC) anesthetic delivery. The primary objective was to determine whether, compared to conventional anesthesia practice, EtC achieves and maintains clinician-specified EtAA and end-tidal oxygen (Et o2 ) concentrations within defined noninferiority limits. Noninferiority was concluded if the lower limit of the 95% confidence interval (CI) of the difference between the percent duration within the acceptable range (5% of steady state or a margin of ~10% of each agent's minimum alveolar concentration) for EtC and MC was ≥ -5% for both EtAA and Et o2 . Secondary objectives included performance measures: response time: time required to attain 90% of the first desired EtAA, overshoot: amount the controller (or vaporizer delivery) exceeded the desired EtAA, and accuracy: average deviation from the desired EtAA.

Results: EtC achieved and sustained targeted EtAA and Et o2 concentrations within the noninferiority threshold. The EtAA was within 5% of the desired value 98% ± 2.05% of the time with EtC compared to 45.7% ± 31.7% of the time with MC (difference 52.3% [95% CI, 45.9%-58.6%], P < .0001). For Et o2 , EtC was within the noninferiority limit 86.3% ± 22.8% of the time compared with MC at 41% ± 33.3% ( P < .0001, difference 45.3% [95% CI, 36.1%-54.5%]). The median response time for achieving 90% of the initial EtAA desired value was 75 seconds with EtC and 158 seconds with MC ( P = .0013). EtC exhibited a median overshoot of 6.64% of the selected EtAA concentration, whereas MC often failed to reach the clinician's desired value. The difference in median percent deviation from desired EtAA value was 15.7% ([95% CI, 13.5%-19.0%], P < 0001).

Conclusions: EtC achieves and maintains the EtAA and Et o2 concentration in a manner that is noninferior to manually controlled anesthesia delivery.

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潮气末控制与人工控制吸入麻醉给药:随机对照非劣效性试验。
背景:精确的麻醉给药有助于确保失忆、镇痛和不动。传统的方法是通过手动调节新鲜气体流量和麻醉剂蒸发器输出来维持潮气末麻醉浓度。一些麻醉给药系统可以使用改进的闭环系统输送并维持临床医生选择的潮气末麻醉剂(EtAA)浓度。我们评估了 Aisys CS2 麻醉机(GE HealthCare)上潮气末控制 (EtC) 系统的性能。我们假设 EtC 系统的麻醉剂给药效果不会劣于手动控制的麻醉剂给药效果:多点麻醉随机对照潮气末控制与传统结果比较研究(MASTER)试验评估了 210 名接受吸入麻醉的成人患者的麻醉给药情况。患者被随机分配到潮气末控制(ETC)或人工控制(MC)麻醉给药。主要目的是确定与传统麻醉方法相比,EtC 是否能达到并维持临床医生指定的 EtAA 和潮气末氧 (Eto2) 浓度在规定的非劣性范围内。如果 EtC 和 MC 的 EtAA 和 Eto2 在可接受范围(稳态的 5% 或每种药剂的最低肺泡浓度的 ~10% 的余量)内的持续时间百分比之差的 95% 置信区间 (CI) 的下限≥ -5%,则判定为非劣效性。次要目标包括性能测量:响应时间:达到首次预期 EtAA 的 90% 所需的时间;过冲:控制器(或蒸发器输送)超出预期 EtAA 的量,以及准确性:与预期 EtAA 的平均偏差:结果:EtC 达到并维持了目标 EtAA 和 Eto2 浓度,在非劣效阈值范围内。使用 EtC 时,EtAA 在期望值的 5% 以内的比例为 98% ± 2.05%,而使用 MC 时为 45.7% ± 31.7%(差异为 52.3% [95% CI, 45.9%-58.6%], P < .0001)。对于 Eto2,EtC 有 86.3% ± 22.8% 的时间在非劣效限内,而 MC 为 41% ± 33.3%(P < .0001,差异为 45.3% [95% CI, 36.1% - 54.5%])。达到 90% 初始 EtAA 预期值的中位响应时间,EtC 为 75 秒,MC 为 158 秒(P = .0013)。EtC 的中位超调为所选 EtAA 浓度的 6.64%,而 MC 往往达不到临床医生的期望值。与预期 EtAA 值的中位偏差百分比差异为 15.7%([95% CI, 13.5%-19.0%], P < 0001):EtC能达到并维持EtAA和Eto2浓度,其效果不亚于人工控制麻醉给药。
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来源期刊
Anesthesia and analgesia
Anesthesia and analgesia 医学-麻醉学
CiteScore
9.90
自引率
7.00%
发文量
817
审稿时长
2 months
期刊介绍: Anesthesia & Analgesia exists for the benefit of patients under the care of health care professionals engaged in the disciplines broadly related to anesthesiology, perioperative medicine, critical care medicine, and pain medicine. The Journal furthers the care of these patients by reporting the fundamental advances in the science of these clinical disciplines and by documenting the clinical, laboratory, and administrative advances that guide therapy. Anesthesia & Analgesia seeks a balance between definitive clinical and management investigations and outstanding basic scientific reports. The Journal welcomes original manuscripts containing rigorous design and analysis, even if unusual in their approach.
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