No registrations found.
ID
Source
Brief title
Health condition
Orthopedic surgery
(NLD: Orthopedische operatie).
Sponsors and support
Den Dolech 2
5600 MB Eindhoven
Den Dolech 2
5600 MB Eindhoven
Intervention
Outcome measures
Primary outcome
1. 14 skin temperatures;
2. rectal temperature;
3. wound surface temperature.
Secondary outcome
Afterwards, the measured temperatures will be compared to the prediction of the computer model developed at the Technical University of Eindhoven.
Background summary
Objective:
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.
Study objective
Obtain 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.
Study design
1. 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.
Intervention
8 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.
Wouter Marken Lichtenbelt, van
P.O. Box 616
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881629
markenlichtenbelt@maastrichtuniversity.nl
Wouter Marken Lichtenbelt, van
P.O. Box 616
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881629
markenlichtenbelt@maastrichtuniversity.nl
Inclusion criteria
1. BMI<=30 kg/m^2;
2. age 18-70;
3. patient undergoing orthopedic back surgery;
4. Caucasian.
Exclusion criteria
1. BMI>30 kg/m^2;
2. age <18 or >70;
3. Diabetes Mellitus;
4. Cardiovascular diseases;
5. Non-Caucasian.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1143 |
| NTR-old | NTR1185 |
| Other | : MEC 07-3-097 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
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