Clinical trial NCT06370676: Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location
Official title: Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergencies
Hypothermia
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ASA \>3
* 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).

Primary outcomes:
measure: Difference in core body temperature between the two tip positions
timeFrame: 20 minutes after cold air exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: TerraXCube
Study officials:
affiliation: Institute of Mountain Emergency Medicine, Eurac Research
name: Simon Rauch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: