目的:围手术期的温度监测通常代表准确性之间的折衷,探针放置的侵入性,和病人的舒适。使用零热通量(ZHF)和双传感器(DS)技术的经皮传感器已在各种临床环境中开发和评估。本研究是第一个将两种传感器的性能与Swan-Ganz导管(PAC)在心脏手术后入住重症监护病房(ICU)的患者中测量的温度同时进行比较的研究。
方法:在这项单中心前瞻性观察研究中,患者术后被转移到ICU,两个传感器都被放置在患者的额头上。由术中放置的PAC测量的核心体温是金标准。以5分钟的间隔记录测量结果,每位患者记录多达40个数据集。Bland和Altman的重复测量方法用于分析一致性。性别亚组分析,身体质量指数,核心温度,进行气道状态和不同的时间间隔。计算了林氏一致性相关系数(LCCC),以及检测高温(≥38°C)和低温(<36°C)的敏感性和特异性。
结果:在六个月的时间内,我们收集了1600套DS,ZHF,和PAC测量,共40名患者。Bland-Altman分析显示,DS和ZHF的平均偏差为-0.82±1.27°C(平均±95%协议极限(LoA))和-0.54±1.14°C,分别。LCCC为0.5(DS)和0.63(ZHF)。高热和低热患者的平均偏倚明显更高。高热的敏感性和特异性分别为0.12/0.99(DS)和0.35/1.0(ZHF),低温为0.95/0.72(DS)和1.0/0.85(ZHF)。
结论:核心温度通常被非侵入性方法低估。在我们的研究中,ZHF的表现优于DS。在协议方面,两种传感器的结果均超出了临床可接受的范围.然而,当没有更多的侵入性方法时,两种传感器可能足以可靠地检测术后低体温.
背景:德国临床试验注册(DRKS-ID:DRKS00027003),回顾性注册2021年10月28日。
Temperature monitoring in the perioperative setting often represents a compromise between accuracy, invasiveness of probe placement, and patient comfort. Transcutaneous sensors using the Zero-Heat-Flux (ZHF) and Double-Sensor (DS) technology have been developed and evaluated in a variety of clinical settings. The present
study is the first to compare the performance of both sensors simultaneously with temperature measured by a Swan-Ganz catheter (PAC) in patients admitted to the intensive care unit (ICU) after cardiac surgery.
In this monocentric prospective observational
study patients were postoperatively transferred to the ICU and both sensors were placed on the patients\' foreheads. Core body temperature measured by intraoperatively placed PAC served as gold standard. Measurements were recorded at 5-minute intervals and up to 40 data sets per patient were recorded. Bland and Altman\'s method for repeated measurements was used to analyse agreement. Subgroup analyses for gender, body-mass-index, core temperature, airway status and different time intervals were performed. Lin\'s concordance correlation coefficient (LCCC) was calculated, as well as sensitivity and specificity for detecting hyperthermia (≥ 38 °C) and hypothermia (< 36 °C).
Over a period of six month, we collected 1600 sets of DS, ZHF, and PAC measurements, from a total of 40 patients. Bland-Altman analysis revealed a mean bias of -0.82 ± 1.27 °C (average ± 95% Limits-of-Agreement (LoA)) and - 0.54 ± 1.14 °C for DS and ZHF, respectively. The LCCC was 0.5 (DS) and 0.63 (ZHF). Mean bias was significantly higher in hyperthermic and hypothermic patients. Sensitivity and specificity were 0.12 / 0.99 (DS) and 0.35 / 1.0 (ZHF) for hyperthermia and 0.95 / 0.72 (DS) and 1.0 / 0.85 (ZHF) for hypothermia.
Core temperature was generally underestimated by the non-invasive approaches. In our
study, ZHF outperformed DS. In terms of agreement, results for both sensors were outside the range that is considered clinically acceptable. Nevertheless, both sensors might be adequate to detect postoperative hypothermia reliably when more invasive methods are not available or appropriate.
German Register of Clinical Trials (DRKS-ID: DRKS00027003), retrospectively registered 10/28/2021.