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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06370676
Acronym
ESO-TIP
Enrollment
15
Registered
2024-04-17
Start date
2024-05-23
Completion date
2024-12-31
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Hypothermia

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.

Interventions

DIAGNOSTIC_TESTOesophageal temperature measurement

Oesophageal temperature measurement

Sponsors

Institute of Mountain Emergency Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Difference in core body temperature between the two tip positions20 minutes after cold air exposureDifference 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026