Nemeth Marcus, Klose Katharina, Asendorf Thomas, Pancaro Carlo, Mielke Benjamin, Fazliu Albulena, Saager Leif, Bräuer Anselm, Miller Clemens
From the Department of Anaesthesiology (MN, KK, BM, AF, LS, AB, CM), Department of Medical Statistics, University Medical Centre Goettingen, Goettingen, Germany (MN, KK, TA, BM, AF, LS, AB, CM), Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan (CP), Outcomes Research Consortium, Cleveland, Ohio, USA (LS).
Eur J Anaesthesiol. 2023 Mar 1;40(3):198-207. doi: 10.1097/EJA.0000000000001796. Epub 2023 Jan 9.
Monitoring peri-operative body temperature in children is currently mainly achieved through invasive devices. The Temple Touch Pro Temperature Monitoring System estimates core temperature noninvasively based on heat flux thermometry.
To investigate the agreement of this noninvasive sensor against standard oesophageal core temperature.
A prospective observational study.
University hospital recruiting between April and July 2021.
One hundred children (32 girls) aged 6 years or younger scheduled for noncardiac surgery, resulting in 6766 data pairs. Exclusion criteria were contraindication for the insertion of an oesophageal temperature probe, and procedures in which one of the measurement methods would interfere with the surgical field.
Primary outcome was the agreement analysis by a Bland-Altman comparison with multiple measurements. Posthoc, we performed another agreement analysis after exclusion of a statistically determined equilibration time. Secondary outcomes were the temperature differences over time and subgroup analysis of hypothermic, normothermic and hyperthermic temperature ranges, age, sex and sensor's side by type III analysis of variance. Further, we correlated the sonographically determined depth of the artery with trueness.
The mean difference was -0.07°C (95% CI -0.15 to +0.05) with limits of agreement of -1.00 and +0.85°C. After adjusting for an equilibration time of 13 min, the mean difference improved to -0.04°C (95% CI -0.08 to +0.01) with limits of agreement of -0.68 and +0.60°C. Concordance correlation coefficient was 0.83 (95% CI 0.82 to 0.84). Differences between the skin sensor and oesophageal reference increased over time by -0.05°C per hour. Subgroup analysis showed no clinically relevant differences. Depth of artery negatively correlated with trueness by 0.03°C per millimetre.
Although the Temple Touch Pro sensor showed acceptable accuracy after allowing for an equilibration time, it still needs further investigation for routine use in children. This particularly affects accuracy in hypothermic ranges, imprecise positioning and applicability in children with immature or vulnerable skin.
German Clinical Trials Register, identifier: DRKS00024703.
目前,儿童围手术期体温监测主要通过侵入性设备实现。Temple Touch Pro体温监测系统基于热通量测温法无创估计核心体温。
研究这种无创传感器与标准食管核心体温的一致性。
一项前瞻性观察性研究。
2021年4月至7月期间招募患者的大学医院。
100名6岁及以下计划进行非心脏手术的儿童(32名女孩),共产生6766对数据。排除标准为食管温度探头插入的禁忌症,以及其中一种测量方法会干扰手术视野的手术。
主要结局是通过Bland-Altman比较和多次测量进行一致性分析。事后,在排除统计学确定的平衡时间后,我们进行了另一项一致性分析。次要结局是随时间的温度差异,以及通过方差分析对低温、正常体温和高温范围、年龄、性别和传感器侧别进行亚组分析。此外,我们将超声确定的动脉深度与准确性进行了相关性分析。
平均差异为-0.07°C(95%CI -0.15至+0.05),一致性界限为-1.00和+0.85°C。在调整13分钟的平衡时间后,平均差异改善至-0.04°C(95%CI -0.08至+0.01),一致性界限为-0.68和+0.60°C。一致性相关系数为0.83(95%CI 0.82至0.84)。皮肤传感器与食管参考值之间的差异每小时增加-0.05°C。亚组分析显示无临床相关差异。动脉深度与准确性呈负相关,每毫米为-0.03°C。
尽管Temple Touch Pro传感器在考虑平衡时间后显示出可接受的准确性,但仍需进一步研究其在儿童中的常规应用。这尤其影响低温范围内的准确性、定位不精确以及在皮肤未成熟或脆弱儿童中的适用性。
德国临床试验注册中心,标识符:DRKS00024703。