NCT07574736

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Dec 2025Jul 2026

Study Start

First participant enrolled

December 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 28, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Agreement between TEE-confirmed insertion depth and landmark-based insertion depth

    Agreement between TEE-confirmed insertion depth and landmark-based insertion depth

    Periprocedural

Study Arms (1)

Adult ICU patients undergoing clinically indicated transesophageal echocardiography

Adult ICU patients undergoing clinically indicated transesophageal echocardiography

Procedure: Transesophageal Echocardiography

Interventions

Transesophageal Echocardiography

Adult ICU patients undergoing clinically indicated transesophageal echocardiography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ICU patients undergoing clinically indicated transesophageal echocardiography

You may qualify if:

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

You may not qualify if:

  • \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

F. Tappeiner Hospital

Merano, BZ, 39012, Italy

RECRUITING

Related Publications (1)

  • 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: 41035569BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Rauch, MD, PhD

    Azienda Sanitaria dell'Alto Adige

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Rauch, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 8, 2026

Study Start

December 12, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations