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临床试验/NCT06370676
NCT06370676已完成不适用

Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location

Institute of Mountain Emergency Medicine1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Difference in core body temperature between the two tip positions

研究概览

简要总结

Background An accurate measurement of the core body temperature (CBT) is of pivotal importance in the management of severely hypothermic patients. For instance, triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT. CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting, with the tip of the probe placed into the distal third of the oesophagus (i.e., posteriorly to the heart and distal to the tracheal bifurcation). However, the correct placement of the probe tip cannot be verified in the prehospital setting, and it is unknown how incorrect placement affects temperature readings.

Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements (i.e., temperature readings not reflecting the real CBT). Particularly, a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings, especially when the patient is ventilated with cold air. The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement.

Methods Experimental, interventional study on 16 healthy volunteers. During the test oesophageal temperature is measured while participants are breathing ambient air first at 20°C (baseline) followed by cold (-20°C) ambient air in supine position for 20 minutes each test in an environmental simulator (terraXcube). Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus (i.e., correct position) or too high in the oesophagus, i.e. behind the trachea.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

The participant is blinded for the location of the oesophageal temperature probe tip.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers with an American Society of Anaesthesiologists (ASA) score ≤2.

排除标准

  • Age < 18 and age >75
  • Pregnant women
  • No signed informed consent
  • Signs and symptoms of an acute illness on the study day
  • History of oesophageal and nasopharyngeal disorders
  • Allergies to Local Anaesthetics (i.e. Lidocain).

结局指标

主要结局

Difference in core body temperature between the two tip positions

时间窗: 20 minutes after cold air exposure

Difference in core body temperature between the two tip positions (i.e. in the lower third of the oesophagus (behind the left atrium) and in the middle third of the oesophagus (behind the trachea)

次要结局

未报告次要终点

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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