MonitoringESOTIP-TEENCT07574736
ESOTIP-TEE: Defining an Easy Landmark to Guide Correct Esophageal Probe Placement With Transesophageal Echocardiography
An observational study of Monitoring and Esophageal Temperature, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monitoring, Esophageal Temperature, Hypothermia
- What is being tested?
- Transesophageal Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2025to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult ICU patients undergoing clinically indicated transesophageal echocardiography
Who may be able to join
- Adult (≥18 years) patients admitted to the ICU
- Clinical indication to perform a transesophageal echocardiography
Who cannot join
- <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
F. Tappeiner Hospital
Merano, BZ, 39012
Simon Rauch, +393404967398, simon.rauch@sabes.it
About this study
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.
Read the 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.
- Conditions
- Monitoring, Esophageal Temperature, Hypothermia
- Being tested
- Transesophageal Echocardiography
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal EchocardiographyProcedure or surgery
Transesophageal Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Adult ICU patients undergoing clinically indicated transesophageal echocardiography | Adult ICU patients undergoing clinically indicated transesophageal echocardiography Receives: Procedure: Transesophageal Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between TEE-confirmed insertion depth and landmark-based insertion depth
Agreement between TEE-confirmed insertion depth and landmark-based insertion depth
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start12 Dec 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Rauch, Institute of Mountain Emergency Medicine
- Investigators
- Simon Rauch, MD, PhD, Principal investigator, Azienda Sanitaria dell'Alto Adige
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574736
- Sponsor's protocol ID
- ESOTIP-TEE
- Acronym
- ESOTIP-TEE
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41035569
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESOTIP-TEE: Defining an Easy Landmark to Guide Correct Esophageal Probe Placement With Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT07574736
- Acronym / sponsor ID
- ESOTIP-TEE / ESOTIP-TEE
- Conditions
- Monitoring, Esophageal Temperature, Hypothermia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU patients undergoing clinically indicated transesophageal echocardiography | – | Procedure: Transesophageal EchocardiographyAdult ICU patients undergoing clinically indicated transesophageal echocardiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult ICU patients undergoing clinically indicated transesophageal echocardiography
Key inclusion criteria (2 listed)
- Adult (≥18 years) patients admitted to the ICU
- Clinical indication to perform a transesophageal echocardiography
Key exclusion criteria (1 listed)
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal EchocardiographyTransesophageal Echocardiography | Procedure or surgery | Adult ICU patients undergoing clinically indicated transesophageal echocardiography |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 41035569Roveri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Rauch, MD, PhD principal investigator
Azienda Sanitaria dell'Alto Adige
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring and Esophageal Temperature, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Rauch, MD, PhD (+393404967398, simon.rauch@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between TEE-confirmed insertion depth and landmark-based insertion depth (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07574736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.