Target-controlled infusion: A comparative, prospective, observational study of the conventional TCI pump and the novel smartphone-based application iTIVA

S. Shah, R. Chawla, Manish Gupta
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Abstract

Empirically adjusted, standard drug doses fail to address interindividual pharmacokinetic and pharmacodynamics variability. Target-controlled infusion (TCI) delivers drugs in calibrated boluses to achieve and maintain a selected target plateau drug level (plasma or effect site). Interactive total intravenous anesthesia (iTIVA™) smartphone software simulates TCI and employs 31 established pharmacokinetic models for 11 different intravenous agents and is coupled with standard volumetric infusion pumps for administering TCI. This prospective, observational, study investigates the degree of agreement between iTIVA and a conventional TCI pump (CTP) for the volume of propofol infused using the Schnider pharmacokinetic model in adult patients of either sex undergoing oncosurgery lasting 1–3 h under total intravenous anesthesia. Bland–Altman analysis of 124 data pairs from 30 patients provided bias, precision, and limits of agreement between the volumes infused by CTP and iTIVA (V-CTP and V-iTIVA) during specific identical time periods. Spearman’s rho and Kendall’s tau rank correlation coefficients provided the degree of association between V-CTP and V-iTIVA. Spearman’s rho and Kendall’s tau were 0.996 and 0.964, respectively. Bias or the mean of differences was −0.02, while the limits of agreement were 0.58 and −0.63, respectively (Bland–Altman plot). The maximum allowed difference of 2 ml was much larger than the 95% confidence intervals for the limits of agreement. The Mountain plot was short tailed (−1.28 to 1.55) and centred over zero (0.01). The volume of propofol infused using TCI pump was similar to that calculated by iTIVA in identical time periods, confirming the clinical applicability of iTIVA.
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目标控制输液:传统 TCI 泵和基于智能手机的新型应用 iTIVA 的前瞻性观察比较研究
经验性调整的标准药物剂量无法解决个体间药代动力学和药效学的差异。目标控制输注(TCI)以校准的栓剂给药,以达到并维持选定的目标高原药物水平(血浆或作用部位)。交互式全静脉麻醉(iTIVA™)智能手机软件可模拟 TCI,并针对 11 种不同的静脉注射药物采用了 31 种已建立的药代动力学模型,还可与标准容积式输液泵配合使用,以实施 TCI。 这项前瞻性、观察性研究调查了 iTIVA 和传统 TCI 泵 (CTP) 使用施奈德药代动力学模型计算异丙酚输注量的一致程度,研究对象是在全静脉麻醉下接受持续 1-3 小时手术的成年男女患者。对来自 30 名患者的 124 对数据进行了 Bland-Altman 分析,结果显示了 CTP 和 iTIVA(V-CTP 和 V-iTIVA)在特定相同时间段内输注量的偏差、精确度和一致性极限。Spearman's rho 和 Kendall's tau 等级相关系数提供了 V-CTP 和 V-iTIVA 之间的关联度。 Spearman's rho 和 Kendall's tau 分别为 0.996 和 0.964。偏差或差异平均值为-0.02,而一致性界限分别为 0.58 和 -0.63(布兰-阿尔特曼图)。允许的最大差异为 2 毫升,远远大于 95% 置信区间的一致限。山形图呈短尾状(-1.28 至 1.55),以零(0.01)为中心。 在相同的时间段内,使用 TCI 泵输注的异丙酚量与 iTIVA 计算的异丙酚量相似,这证实了 iTIVA 的临床适用性。
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