Compare the performance of an unobtrusive new medical device with a CE-marked esophageal and/or rectal reference sensor (Covedien Mon-a-Therm, General Purpose Temperature Probe 400TM) for core body temperature in patients undergoing surgery in which…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chirurgische en medische verrichtingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Core temp values
Secondary outcome
Not applicable
Background summary
Core temperature is the best single indicator of thermal status in humans.
Currently obtrusive probes are used to measure it during operations. These
include esophageal, rectal or bladder probes, which can be obtrusive to
patients, cause irritation or bleeding, and create a risk of infection. Our
goal is develop a new medical device (disposable single sensor) that is
reliable, comfortable and non-invasive and which provides a continuous
measurement to follow the patient for the all duration of hospital stay and to
replace the invasive probes (rectal, esophageal and bladder) overcoming the
related problems.
Study objective
Compare the performance of an unobtrusive new medical device with a CE-marked
esophageal and/or rectal reference sensor (Covedien Mon-a-Therm, General
Purpose Temperature Probe 400TM) for core body temperature in patients
undergoing surgery in which core temperature management is part of standard
procedure (Applying the covedien esophageal and/or rectal sensor is part of
this standard procedure). The study focus is on stability and accuracy. This is
one of the preliminary steps to come to a low-cost and easy-to-use core body
temperature measurement system for in hospital use.
Study design
Observational study
Study burden and risks
Not applicable
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
Adult (*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. (In ETZ bladder sensors are not routinely used).
Exclusion criteria
Exclusion criteria are: neuro-trauma, known pregnancy, prone position during surgery, obesity (BMI>40), and a significant language barrier that prevents the patient from understanding the Informed Consent or answering the questionnaire.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56401.028.16 |
| OMON | NL-OMON26681 |