- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07574736
ESOTIP-TEE: Defining an Easy Landmark to Guide Correct Esophageal Probe Placement With Transesophageal Echocardiography (ESOTIP-TEE)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Simon Rauch, MD, PhD
- Phone Number: +393404967398
- Email: simon.rauch@sabes.it
Study Locations
-
-
BZ
-
Merano, BZ, Italy, 39012
- Recruiting
- F. Tappeiner Hospital
-
Contact:
- Simon Rauch
- Phone Number: +393404967398
- Email: simon.rauch@sabes.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (≥18 years) patients admitted to the ICU
- Clinical indication to perform a transesophageal echocardiography
Exclusion Criteria:
- <18 years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult ICU patients undergoing clinically indicated transesophageal echocardiography
|
Transesophageal Echocardiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement between TEE-confirmed insertion depth and landmark-based insertion depth
Time Frame: Periprocedural
|
Agreement between TEE-confirmed insertion depth and landmark-based insertion depth
|
Periprocedural
|
Collaborators and Investigators
Investigators
- Principal Investigator: Simon Rauch, MD, PhD, Azienda Sanitaria dell'Alto Adige
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESOTIP-TEE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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