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Recruiting NCT07574736

ESOTIP-TEE: Defining an Easy Landmark to Guide Correct Esophageal Probe Placement With Transesophageal Echocardiography

Observational Monitoring Esophageal Temperature Hypothermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transesophageal Echocardiography.
Who it may be relevant to
Registry conditions: Monitoring, Esophageal Temperature, Hypothermia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This prospective observational study aims to identify simple external anatomical landmarks that allow reliable prediction of correct esophageal probe insertion depth. Accurate placement in the lower third of the esophagus is essential for reliable core temperature monitoring. Transesophageal echocardiography (TEE) will be used as the reference standard to confirm correct probe position. The study will evaluate the agreement between landmark-based insertion depth and TEE-confirmed placement in adult ICU patients undergoing clinically indicated TEE.

Detailed description

Correct placement of esophageal probes is essential for accurate core temperature measurement. Misplacement can lead to clinically relevant errors. Existing placement strategies based on fixed insertion depths or patient height show limited accuracy.

This study investigates whether combinations of simple external anatomical landmarks can predict the correct insertion depth. During clinically indicated TEE, probe position will be verified, and multiple anatomical measurements will be recorded. Agreement between predicted and TEE-confirmed insertion depth will be assessed using Bland-Altman analysis and intraclass correlation coefficients.

Interventions

  • Procedure Transesophageal Echocardiography
    Transesophageal Echocardiography

Primary outcome measures

  • Agreement between TEE-confirmed insertion depth and landmark-based insertion depth [Time frame: Periprocedural]

Eligibility criteria

Inclusion criteria

  • Adult (≥18 years) patients admitted to the ICU
  • Clinical indication to perform a transesophageal echocardiography

Exclusion criteria

  • <18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • F. Tappeiner Hospital — Merano

Publications

  • Roveri G, Dal Cappello T, Hofer A, Breidt F, Kofler O, Popp E, Brugger H, Rauch S. Influence of esophageal temperature probe tip placement on core temperature measurement accuracy in cold environments: a randomized crossover trial with implications for cardiac arrest management. Resusc Plus. 2025 Sep 4;26:101087. doi: 10.1016/j.resplu.2025.101087. eCollection 2025 Nov. PMID 41035569

Identifiers

NCT: NCT07574736 · ESOTIP-TEE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗