HypothermiaTempNCT02220101
Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods
An observational study of Hypothermia and Hyperthermia, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial summary
Comparison of four methods for measuring temperature perioperatively in patients scheduled for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme; Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothermia, Hyperthermia
- How many people
- 95 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Jan 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Laparoscopic surgery and in ICU patients
Who may be able to join
- Surgical Patient group:
- > 18 years
- ASA 1-3
- Laparoscopic surgery
- Elective surgery
- Intensive Patient group:
Show all 9Show fewer
- > 18 years
- Defined as intensive patient
- ASA 1-5
Who cannot join
- Surgical Patient group:
- BMI> 30 kg/m2
- No bladder (ileum-bladder)
- Known malignant hyperthermia
- Malformations of the face that prevents nasopharynx and temporal scanner measurements
- Patient is participating in another study that may influence the results of the Tempstudy
Show all 17Show fewer
- The patient is not competent to give consent, eg severe dementia
- The patient INR> 2.0 and / or Trc <50
- Intensive Patient group:
- BMI> 30 kg/m2
- No bladder (ileum-bladder)
- Malformations of the face that prevents nasopharynx and temporal scanner measurements
- Hypothermic patient below 32 ° C (bladder temperature)
- Hyperterm patient over 40 ° C (bladder temperature)
- Active cooling of the bladder
- The patient is under ongoing cooling or heating
- Patient is participating in another study that may influence the results of the Tempstudy
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of four methods for measuring temperature perioperatively in patients scheduled for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme; Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner. The study is a single-center, observational study carried out by the Central Surgical and Intensive Section at Vestfold Hospital Trust.
Read the detailed description
Issues
- Perioperative hypothermia is associated with several serious complications and therefore most likely to be avoided. Monitoring of body temperature is therefore required perioperatively .
- There are in the literature concerns that some methods of measuring temperature perioperatively is accurate enough and whether they reflect core temperature adequate.
- Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) - measurements are accurate enough to measure the actual core temperature. Much of the research on TS measurements have been done on children and newborns in an intensive setting, but little perioperatively .
A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied Regional Ethics Committee. Patients will not get different treatment than standard treatment in hospital and it causes no follow-up calls or hospital visits. All patients (if possible) give written consent for participation.
- Conditions
- Hypothermia, Hyperthermia
- Keywords
- hypothermia, core temperature, temperature measurement methods
- Medical subject headings
- Hypothermia, Hyperthermia
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature difference measured with different measuring methods
The difference in temperature between the temperature measured by the current reference method bladder temperature and the temperature measured with Temporal Scanner, SpotOn and nasopharynx through the entire operational sequence (from first to last measurement) and three individual measurements at 20 minute intervals of intensive care patients.
Measured: Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute)
Secondary outcomes (1)
Number of patients with 1) Sore after Sticker (SpotOn) 2) epistaxis during hospital stay as a measure of safety and tolerability.
An average of 10 days
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2023
- Study completionJan 2023
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Espen Lindholm, Sykehuset i Vestfold HF
- Investigators
- Espen Lindholm, M.D., Study director, Departement of Anesthesiology, Vestfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220101
- Sponsor's protocol ID
- 1A
- Acronym
- Temp
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2014
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods
- ClinicalTrials.gov ID
- NCT02220101
- Acronym / sponsor ID
- Temp / 1A
- Conditions
- Hypothermia, Hyperthermia
- Keywords
- hypothermia, core temperature, temperature measurement methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Apr 2014
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 19 Aug 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.
Comparison of four methods for measuring temperature perioperatively in patients scheduled for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme; Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner. The study is a single-center, observational study carried out by the Central Surgical and Intensive Section at Vestfold Hospital Trust.
Detailed description
Issues
- Perioperative hypothermia is associated with several serious complications and therefore most likely to be avoided. Monitoring of body temperature is therefore required perioperatively .
- There are in the literature concerns that some methods of measuring temperature perioperatively is accurate enough and whether they reflect core temperature adequate.
- Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) - measurements are accurate enough to measure the actual core temperature. Much of the research on TS measurements have been done on children and newborns in an intensive setting, but little perioperatively .
A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied Regional Ethics Committee. Patients will not get different treatment than standard treatment in hospital and it causes no follow-up calls or hospital visits. All patients (if possible) give written consent for participation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Laparoscopic surgery and in ICU patients
Key inclusion criteria (9 listed)
- > 18 years
- ASA 1-3
- Laparoscopic surgery
- Elective surgery
- > 18 years
Key exclusion criteria (17 listed)
- BMI> 30 kg/m2
- No bladder (ileum-bladder)
- Known malignant hyperthermia
- Malformations of the face that prevents nasopharynx and temporal scanner measurements
- Patient is participating in another study that may influence the results of the Tempstudy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temperature difference measured with different measuring methods
Time frame: Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute)
The difference in temperature between the temperature measured by the current reference method bladder temperature and the temperature measured with Temporal Scanner, SpotOn and nasopharynx through the entire operational sequence (from first to last measurement) and three individual measurements at 20 minute intervals of intensive care patients.
1 secondary outcome
Number of patients with 1) Sore after Sticker (SpotOn) 2) epistaxis during hospital stay as a measure of safety and tolerability.
Time frame: Hospital discharge
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 4 Jan 2023.
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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.
Espen Lindholm, M.D. study director
Departement of Anesthesiology, Vestfold Hospital Trust
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 and Hyperthermia, run by Sykehuset i Vestfold HF 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 9 inclusion and 17 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 4 Jan 2023. 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?
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 difference measured with different measuring methods (time frame: Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute)). 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 4 Jan 2023.