EmergenciesESO-TIPNCT06370676
Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location
A study testing Oesophageal temperature measurement in people with Emergencies and Hypothermia, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Hypothermia
- What is being tested?
- Oesophageal temperature measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 23 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers with an American Society of Anaesthesiologists (ASA) score ≤2.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Emergencies, Hypothermia
- Being tested
- Oesophageal temperature measurement
- Medical subject headings
- Emergencies, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oesophageal temperature measurementDiagnostic test
Oesophageal temperature measurement
| Study group | Role | What they receive |
|---|---|---|
| Correctly placed oesophageal probe at +20 degrees celsius ambient temperature | Active comparator | Oesophageal probe tip located in the lower third of the oesophagus, i.e. behind the left atrium, +20°C ambient temperature, outside terraXcube Receives: Diagnostic Test: Oesophageal temperature measurement |
| Oesophageal probe tip too high at +20 degrees celsius ambient temperature | Experimental | Oesophageal probe tip located too high the oesophagus, i.e. behind the trachea, 1-2 cm above the level of the tracheal bifurcation, +20°C ambient temperature, outside terraXcube Receives: Diagnostic Test: Oesophageal temperature measurement |
| Correctly placed oesophageal probe at -20 degrees celsius ambient temperature | Active comparator | Oesophageal probe tip located in the lower third of the oesophagus, i.e. behind the left atrium, -20°C ambient temperature, inside terraXcube Receives: Diagnostic Test: Oesophageal temperature measurement |
| Oesophageal probe tip too high at -20 degrees celsius ambient temperature | Experimental | Oesophageal probe tip located too high the oesophagus, i.e. behind the trachea, 1-2 cm above the level of the tracheal bifurcation, -20°C ambient temperature, inside terraXcube Receives: Diagnostic Test: Oesophageal temperature measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 20 minutes after cold air exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start23 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Rauch, MD, PhD, Principal investigator, Institute of Mountain Emergency Medicine, Eurac Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370676
- Sponsor's protocol ID
- ESO-TIP
- Acronym
- ESO-TIP
- Status last verified
- Aug 2025
- First submitted
- 11 Apr 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location
- ClinicalTrials.gov ID
- NCT06370676
- Acronym / sponsor ID
- ESO-TIP / ESO-TIP
- Conditions
- Emergencies, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Apr 2024 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Correctly placed oesophageal probe at +20 degrees celsius ambient temperature | Active comparator | Diagnostic Test: Oesophageal temperature measurementOesophageal probe tip located in the lower third of the oesophagus, i.e. behind the left atrium, +20°C ambient temperature, outside terraXcube |
| Oesophageal probe tip too high at +20 degrees celsius ambient temperature | Experimental | Diagnostic Test: Oesophageal temperature measurementOesophageal probe tip located too high the oesophagus, i.e. behind the trachea, 1-2 cm above the level of the tracheal bifurcation, +20°C ambient temperature, outside terraXcube |
| Correctly placed oesophageal probe at -20 degrees celsius ambient temperature | Active comparator | Diagnostic Test: Oesophageal temperature measurementOesophageal probe tip located in the lower third of the oesophagus, i.e. behind the left atrium, -20°C ambient temperature, inside terraXcube |
| Oesophageal probe tip too high at -20 degrees celsius ambient temperature | Experimental | Diagnostic Test: Oesophageal temperature measurementOesophageal probe tip located too high the oesophagus, i.e. behind the trachea, 1-2 cm above the level of the tracheal bifurcation, -20°C ambient temperature, inside terraXcube |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers with an American Society of Anaesthesiologists (ASA) score ≤2.
Key exclusion criteria (7 listed)
- ASA >3
- Age < 18 and age >75
- Pregnant women
- No signed informed consent
- Signs and symptoms of an acute illness on the study day
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 |
|---|---|---|
| Oesophageal temperature measurementOesophageal temperature measurement | Diagnostic test | Correctly placed oesophageal probe at +20 degrees celsius ambient temperature, Correctly placed oesophageal probe at -20 degrees celsius ambient temperature, Oesophageal probe tip too high at +20 degrees celsius ambient temperature, Oesophageal probe tip too high at -20 degrees celsius ambient temperature |
Primary outcome
Difference in core body temperature between the two tip positions
Time frame: 20 minutes after cold air exposure
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- 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. This study is not recruiting at the moment.
Simon Rauch, MD, PhD principal investigator
Institute of Mountain Emergency Medicine, Eurac Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oesophageal temperature measurement in people with Emergencies and Hypothermia, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in core body temperature between the two tip positions (time frame: 20 minutes after cold air exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2025.