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van CCT (UK)

van CCT (UK)

Temperature during orthopedic surgery.

- candidate number2939
- NTR NumberNTR1185
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-dec-2007
- Secondary IDsMEC 07-3-097 
- Public TitleTemperature during orthopedic surgery.
- Scientific TitleTemperature during orthopedic surgery.
- ACRONYMTemperature during orthopedic surgery
- hypothesisObtain transient temperature data of the skin, core and wound surface during orthopedic back surgery in order to validate the numerical model of Severens for this type of surgery.
- Healt Condition(s) or Problem(s) studiedOrthopedic surgery
- Inclusion criteria1. BMI<=30 kg/m^2;
2. age 18-70;
3. patient undergoing orthopedic back surgery;
4. Caucasian.
- Exclusion criteria1. BMI>30 kg/m^2;
2. age <18 or >70;
3. Diabetes Mellitus;
4. Cardiovascular diseases;
5. Non-Caucasian.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-mei-2008
- Target number of participants8
- Interventions8 patients will be asked to participate in this study. The following measurements take place:
1. Determination of body characteristics: height, weight and fat percentage at the evening before the surgery. ALso hip and wast circumference will be measured;
2. 14 skin temperature sensors will be attached with tape to the skin, during surgery;
3. Four times per hour pictures will be taken from the wound surface with the help of an infrared camera. The surgery will not be disturbed or delayed by this;
4. Core temperature data (this parameter is measured standard) will be stored. No extra manoeuvre is needed for that. Normally, the data is destroyed after surgery, but now it will be stored;
5. All sensors are removed at the end of the surgery.
- Primary outcome1. 14 skin temperatures;
2. rectal temperature;
3. wound surface temperature.
- Secondary outcomeAfterwards, the measured temperatures will be compared to the prediction of the computer model developed at the Technical University of Eindhoven.
- Timepoints1. November 2007 Writing and submitting METC application;
2. January 2008 - March 2008 Recruiting patients and perform measurements;
3. April 2008 Data analysis;
4. May 2008 & Final report.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Wouter Marken Lichtenbelt, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Wouter Marken Lichtenbelt, van
- Sponsor/Initiator Technische Universiteit Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Technische Universiteit Eindhoven
- PublicationsSeverens N M W, Van Marken Lichtenbelt W D, Frijns A J H, Van Steenhoven A A , De Mol B A J M and Sessler D I 2007 A model to predict patient temperature during cardiac surgery Phys. Med. Biol. 52 (17) 5131-5145
- Brief summaryObjective:
Obtain transient temperature data of the skin, core and wound surface during ortho- pedic back surgery in order to validate the numerical model of Severens etal [7] for this type of surgery.

Study design:
Observational study in which skin temperature is continuously measured with 14 wire-less thermistors and wound surface temperature is measured with an infrared camera 4 times per hour. Rectal temperature data is also stored in the study.

Main study parameters:
14 skin temperatures, rectal temperature and wound surface temperature during or- thopedic surgery. Afterwards the predictions of the computer model that was devel- oped at the Technical University Eindhoven will be compared to the obtained mea- surement results. Nature and extent of the burden and risks associated with participation, bene¯t and group relatedness No risks are involved during the study. The burden of the study is low. Because we are interested in surgeries with larger incisions and with no other complicated interventions, patients who undergo orthopedic surgery are chosen.
- Main changes (audit trail)
- RECORD10-dec-2007 - 17-apr-2008

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