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

Emergencies Clinical Trial

— ESO-TIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370676
• Other study ID #: ESO-TIP
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: April 2024
• Source: Institute of Mountain Emergency Medicine
• Contact: Simon Rauch, MD, PhD
• Phone: 3404967398
• Email: simon.rauch[@]eurac.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: July 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Emergencies
• Hypothermia

Intervention

Diagnostic Test:
• Oesophageal temperature measurement
Oesophageal temperature measurement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in core body temperature between the two tip positions	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)	20 minutes after cold air exposure