Body TemperatureNCT01793337
Core Body Temperature Measurement During Hot and Cold Environmental Exposure
A study testing Exposure to cold environmental temperature (-20°C) in people with Body Temperature and Hypothermia, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial summary
Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Temperature, Hypothermia
- What is being tested?
- Exposure to cold environmental temperature (-20°C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Oct 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- ASA class 1
Who cannot join
- <18 years old
- American society of anesthesiologists class >1
- history of ear, nose, throat surgery
- congenital malformation of head/throat/ear/nose
- absence of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure
Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the Double Sensor device is a non-invasive device and is promising for prehospital use but has not been sufficiently verified under very cold and hot environmental conditions. Furthermore, comparisons of different non-invasive methods with oesophageal measurement in extreme conditions are lacking. The objective of these studies is to compare different techniques of core body temperature measurement with exposure to cold and hot environments.
- Conditions
- Body Temperature, Hypothermia
- Being tested
- Exposure to cold environmental temperature (-20°C)
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to cold environmental temperature (-20°C)Other
| Study group | Role | What they receive |
|---|---|---|
| Cold first | Other | temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards Receives: Other: Exposure to cold environmental temperature (-20°C) |
| Warm first | Other | temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards Receives: Other: Exposure to cold environmental temperature (-20°C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between oesophageal and epitympanic temperature
Measured: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionOct 2012
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 Body TemperatureStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793337
- Sponsor's protocol ID
- V/31/10
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
Publications
Gunga HC, Werner A, Stahn A, Steinach M, Schlabs T, Koralewski E, Kunz D, Belavy DL, Felsenberg D, Sattler F, Koch J. The Double Sensor-A non-invasive device to continuously monitor core temperature in humans on earth and in space. Respir Physiol Neurobiol. 2009 Oct;169 Suppl 1:S63-8. doi: 10.1016/j.resp.2009.04.005. Epub 2009 Apr 14.
PubMed 19428314
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure
- ClinicalTrials.gov ID
- NCT01793337
- Acronym / sponsor ID
- V/31/10
- Conditions
- Body Temperature, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the Double Sensor device is a non-invasive device and is promising for prehospital use but has not been sufficiently verified under very cold and hot environmental conditions. Furthermore, comparisons of different non-invasive methods with oesophageal measurement in extreme conditions are lacking. The objective of these studies is to compare different techniques of core body temperature measurement with exposure to cold and hot environments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold first | Other | Other: Exposure to cold environmental temperature (-20°C)temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards |
| Warm first | Other | Other: Exposure to cold environmental temperature (-20°C)temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years old
- ASA class 1
Key exclusion criteria (5 listed)
- <18 years old
- American society of anesthesiologists class >1
- history of ear, nose, throat surgery
- congenital malformation of head/throat/ear/nose
- absence of informed consent
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 |
|---|---|---|
| Exposure to cold environmental temperature (-20°C) | Other | Cold first, Warm first |
Primary outcome
Difference between oesophageal and epitympanic temperature
Time frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C
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 15 Feb 2013.
- Background: PubMed 19428314Gunga HC, Werner A, Stahn A, Steinach M, Schlabs T, Koralewski E, Kunz D, Belavy DL, Felsenberg D, Sattler F, Koch J. The Double Sensor-A non-invasive device to continuously monitor core temperature in humans on earth and in space. Respir Physiol Neurobiol. 2009 Oct;169 Suppl 1:S63-8. doi: 10.1016/j.resp.2009.04.005. Epub 2009 Apr 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to cold environmental temperature (-20°C) in people with Body Temperature 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 2 inclusion and 5 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 15 Feb 2013. 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 between oesophageal and epitympanic temperature (time frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C). 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 NCT01793337, 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 15 Feb 2013.