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.
ID
Bron
Verkorte titel
Aandoening
Orthopedic surgery
(NLD: Orthopedische operatie).
Ondersteuning
Den Dolech 2
5600 MB Eindhoven
Den Dolech 2
5600 MB Eindhoven
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. 14 skin temperatures;<br>
2. rectal temperature;<br>
3. wound surface temperature.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wouter Marken Lichtenbelt, van
P.O. Box 616
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881629
markenlichtenbelt@maastrichtuniversity.nl
Wetenschappers
Wouter Marken Lichtenbelt, van
P.O. Box 616
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881629
markenlichtenbelt@maastrichtuniversity.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. BMI<=30 kg/m^2;
2. age 18-70;
3. patient undergoing orthopedic back surgery;
4. Caucasian.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. BMI>30 kg/m^2;
2. age <18 or >70;
3. Diabetes Mellitus;
4. Cardiovascular diseases;
5. Non-Caucasian.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1143 |
NTR-old | NTR1185 |
Ander register | : MEC 07-3-097 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
Samenvatting resultaten
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