HypothermiaNCT02009059
Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia
An observational study of Hypothermia, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypothermia
- What is being tested?
- Non-invasive temperature in hypothermia
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2013to Mar 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective thoracic surgery in deep hypothermia
Who may be able to join
- Adult >18 years
- Elektive cardiac surgery in deep hypothermia
- No pathology in ear canal on otoscopy
Who cannot join
- Pathology in ear canal
- non-consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia; a Prospective Cohort Study
In pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia.
Read the detailed description
The study is a prospective cohort study on patients undergoing elective thoracic surgery in deep hypothermia. The goal is to assess the accuracy of non-invasive temperature devices compared to a gold standard representing core temperature.
At the study hospital, Oslo University Hospital Rikshospitalet, patients undergoing thoracic surgery will already have several routes of temperature monitoring as part of standard procedure. Before cardiopulmonary bypass bladder temperature is normally used as a reference for core temperature. After cardiopulmonary bypass is established, temperature is monitored directly in the circulating blood, hence reflecting core temperature.
For measuring the epitympanic temperature we will use the Metraux Epitympanic Thermometer (Walpoth, Galdikas et al. 1994), a nasopharyngeal temperature probe (Mon-a-Therm, General Purpose Temperature Probe 12Fr/Ch, Covidien) and a new transcutaneous device (SpotOn 3M). The temperature will be measured in degrees Celsius. The first reading will be noted just after induction of anaesthesia and compared to the bladder temperature. After cardiopulmonary bypass (CPB) is established and therapeutic hypothermia is induced, the values for both non-invasive and blood temperature will be recorded every minute. After reaching the target temperature according to the blood temperature, we will continue recording the non-invasive temperature until relative similarity is established. The process will be repeated during re-warming.
- Conditions
- Hypothermia
- Being tested
- Non-invasive temperature in hypothermia
- Keywords
- hypothermia, Temperature, epitympanic, pre-hospital
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive temperature in hypothermiaDevice
Also called metraux epitympanic, nasopharyngeal, 3M spotOn
accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive temperature in hypothermia | Adult patients undergoing elective thoracic surgery in deep hypothermia Receives: Device: Non-invasive temperature in hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature in degrees celsius
The temperature reading from the epitympanic thermometer will be recorded every two minutes during deep hypothermia and compared to the temperature measured in the cardiopulmonary bypass circuit.
Measured: The patients will be followed during the induced per-operative hypothermia, an expected average of 1,5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
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
- NCT02009059
- Sponsor's protocol ID
- scs-2013
- Status last verified
- Jan 2015
- First submitted
- 11 Nov 2013
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia; a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02009059
- Acronym / sponsor ID
- scs-2013
- Conditions
- Hypothermia
- Keywords
- hypothermia, Temperature, epitympanic, pre-hospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Dec 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.
In pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia.
Detailed description
The study is a prospective cohort study on patients undergoing elective thoracic surgery in deep hypothermia. The goal is to assess the accuracy of non-invasive temperature devices compared to a gold standard representing core temperature.
At the study hospital, Oslo University Hospital Rikshospitalet, patients undergoing thoracic surgery will already have several routes of temperature monitoring as part of standard procedure. Before cardiopulmonary bypass bladder temperature is normally used as a reference for core temperature. After cardiopulmonary bypass is established, temperature is monitored directly in the circulating blood, hence reflecting core temperature.
For measuring the epitympanic temperature we will use the Metraux Epitympanic Thermometer (Walpoth, Galdikas et al. 1994), a nasopharyngeal temperature probe (Mon-a-Therm, General Purpose Temperature Probe 12Fr/Ch, Covidien) and a new transcutaneous device (SpotOn 3M). The temperature will be measured in degrees Celsius. The first reading will be noted just after induction of anaesthesia and compared to the bladder temperature. After cardiopulmonary bypass (CPB) is established and therapeutic hypothermia is induced, the values for both non-invasive and blood temperature will be recorded every minute. After reaching the target temperature according to the blood temperature, we will continue recording the non-invasive temperature until relative similarity is established. The process will be repeated during re-warming.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive temperature in hypothermia | – | Device: Non-invasive temperature in hypothermiaAdult patients undergoing elective thoracic surgery in deep hypothermia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective thoracic surgery in deep hypothermia
Key inclusion criteria (3 listed)
- Adult >18 years
- Elektive cardiac surgery in deep hypothermia
- 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 |
|---|---|---|
| Non-invasive temperature in hypothermiaAlso: metraux epitympanic, nasopharyngeal, 3M spotOnaccuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature | Device | Non-invasive temperature in hypothermia |
Primary outcome
Temperature in degrees celsius
Time frame: The patients will be followed during the induced per-operative hypothermia, an expected average of 1,5 hours.
The temperature reading from the epitympanic thermometer will be recorded every two minutes during deep hypothermia and compared to the temperature measured in the cardiopulmonary bypass circuit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
Related trials for Hypothermia
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
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
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 Hypothermia, run by Oslo University Hospital at 1 site in Norway.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2015. 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 Norway. 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?
Results are not available in the source record.
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 per-operative hypothermia, an expected average of 1,5 hours.). 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 29 Oct 2015.