HypothermiaNCT02274597
Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?
An observational study of Hypothermia, run by Oslo University Hospital.
Trial summary
The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- metraux epitympanic thermometer
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Adult 18-60 years
- no medication
- healthy, no chronic illness
- no acute illness on study day
- No pathology in ear canal on otoscopy
Who cannot join
- Pathology in ear canal
- non-consent
About this study
The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.
Read the detailed description
The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.
Healthy volunteers will be recruited. As reference value for core temperature we will use a standard rectal probe (Mon-a-Therm, General purpose Temperature Probe 12Fr/Ch, Covidien) attached to an external monitor. The study will be in a field setting in the mountains of Hemsedal, Norway.
For measuring the epitympanic temperature we will use the Metraux Thermometer (Walpoth, Galdikas et al. 1994). The Metraux Thermometer is widely used in pre-hospital care in Norway and internationally. The ear-sensor will after induction of anaesthesia be inserted according to the manufacturers specifications in the auditory canal and activated. The sensor is two tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug. The depth of the measuring point is pre-set from the manufacture to be approximately 10 mm from the tympanic membrane. The display will then show the epitympanic temperature in real-time.
The volunteers will be exposed to four different scenarios. 1. Ambient air with no protection of head/measuring site. 2. Ambient air with local protection of measuring site. 3. Snow in the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 Cold water in the ear canal (to resemble water immersion/submersion).
The temperature will be measured in degrees Celsius. A baseline will be established before exposing the volunteers to the different environmental factors. After exposure the temperature will be recorded every 15 seconds for a total of 10minutes.
- Conditions
- Hypothermia
- Being tested
- metraux epitympanic thermometer
- Keywords
- hypothermia, pre-hospital, epitympanic, temperature
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metraux epitympanic thermometerDevice
accuracy of epitympanic temperature measurement in different environmental settings
| Study group | Role | What they receive |
|---|---|---|
| Environmental impact on epitympanic temperature measurment | volunteers exposed to different environmental factors to simulate field settings Receives: Device: metraux epitympanic thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature in degrees celsius
The temperature will be recorded for a total of 10minutes during four different scenarios and compared to the rectal temperature
Measured: The patients will be followed during the induced environmental factors, an expected average of 1 hour/participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionDec 2014
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 HypothermiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leiv Arne Rosseland, MD,Phd, Study director, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274597
- Sponsor's protocol ID
- scs-2014
- Status last verified
- Oct 2014
- First submitted
- 22 Oct 2014
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Skaiaa SC, Brattebo G, Assmus J, Thomassen O. The impact of environmental factors in pre-hospital thermistor-based tympanic temperature measurement: a pilot field study. Scand J Trauma Resusc Emerg Med. 2015 Sep 24;23:72. doi: 10.1186/s13049-015-0148-5.
PubMed 26400226
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?
- ClinicalTrials.gov ID
- NCT02274597
- Acronym / sponsor ID
- scs-2014
- Conditions
- Hypothermia
- Keywords
- hypothermia, pre-hospital, epitympanic, temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Oct 2014 (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.
The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.
Detailed description
The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.
Healthy volunteers will be recruited. As reference value for core temperature we will use a standard rectal probe (Mon-a-Therm, General purpose Temperature Probe 12Fr/Ch, Covidien) attached to an external monitor. The study will be in a field setting in the mountains of Hemsedal, Norway.
For measuring the epitympanic temperature we will use the Metraux Thermometer (Walpoth, Galdikas et al. 1994). The Metraux Thermometer is widely used in pre-hospital care in Norway and internationally. The ear-sensor will after induction of anaesthesia be inserted according to the manufacturers specifications in the auditory canal and activated. The sensor is two tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug. The depth of the measuring point is pre-set from the manufacture to be approximately 10 mm from the tympanic membrane. The display will then show the epitympanic temperature in real-time.
The volunteers will be exposed to four different scenarios. 1. Ambient air with no protection of head/measuring site. 2. Ambient air with local protection of measuring site. 3. Snow in the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 Cold water in the ear canal (to resemble water immersion/submersion).
The temperature will be measured in degrees Celsius. A baseline will be established before exposing the volunteers to the different environmental factors. After exposure the temperature will be recorded every 15 seconds for a total of 10minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Environmental impact on epitympanic temperature measurment | – | Device: metraux epitympanic thermometervolunteers exposed to different environmental factors to simulate field settings |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- Adult 18-60 years
- no medication
- healthy, no chronic illness
- no acute illness on study day
- No pathology in ear canal on otoscopy
Key exclusion criteria (2 listed)
- Pathology in ear canal
- non-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 |
|---|---|---|
| metraux epitympanic thermometeraccuracy of epitympanic temperature measurement in different environmental settings | Device | Environmental impact on epitympanic temperature measurment |
Primary outcome
Temperature in degrees celsius
Time frame: The patients will be followed during the induced environmental factors, an expected average of 1 hour/participant.
The temperature will be recorded for a total of 10minutes during four different scenarios and compared to the rectal temperature
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 27 Apr 2015.
- Derived from this study: PubMed 26400226Skaiaa SC, Brattebo G, Assmus J, Thomassen O. The impact of environmental factors in pre-hospital thermistor-based tympanic temperature measurement: a pilot field study. Scand J Trauma Resusc Emerg Med. 2015 Sep 24;23:72. doi: 10.1186/s13049-015-0148-5.
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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.
Leiv Arne Rosseland, MD,Phd study director
Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, run by Oslo University Hospital.
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 5 inclusion and 2 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 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Temperature in degrees celsius (time frame: The patients will be followed during the induced environmental factors, an expected average of 1 hour/participant.). 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 NCT02274597, 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 27 Apr 2015.