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Peri-operative, unobtrusive core temperature measurement


- candidate number24666
- NTR NumberNTR5976
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jul-2016
- Secondary IDsNL56401.028.16 Philips Research
- Public TitlePeri-operative, unobtrusive core temperature measurement
- Scientific TitlePeri-operative unobtrusive core temperature measurement a clinical pilot trial
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedTemperature, Surgery
- Inclusion criteria-≥18 years patients planned to undergo surgery with temperature management as standard part of the procedure. These patients are routinely equipped with an (oesophageal and/or rectal) temperature sensor.
- patients where the expected surgery duration is more than 2 hours.
- Exclusion criteria- neuro-trauma
- pregnancy
- prone position during surgery or intensive care
- obesity (BMI>40)
- significant language barrier that prevents the patient from understanding the Informed Consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 6-jul-2016
- planned closingdate
- Target number of participants40
- InterventionsPatients who are undergoing planned surgery in which core temperature management is part of standard procedure (esophageal and/or rectal), will receive extra prototype core temp sensors These sensors are applied in the holding area one hour before the operation starts. Depending on the sensors and its shape it can be applied e.g. behind the ear, on the forehead and/or in the neck.
- Primary outcomeThe comparison of the results from all the sensors
- Secondary outcomeThe observation of the effect of surgery duration and type on the drop in core temperature and observing the comfort and ease of use of the prototype sensors
- TimepointsEvery minute pre-operative and during surgery
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Celine Reverseau
- CONTACT for SCIENTIFIC QUERIES Celine Reverseau
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips Research
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-jul-2016 - 31-aug-2016


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