Clinical trial NCT01795482: Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery
Official title: The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Warming
Prewarming
Perioperative Hypothermia
General Anaesthesia
Epidural Anaesthesia
Temperature Monitoring
Keywords: perioperative hypothermia
prewarming
preoperative warming
general anaesthesia
epidural anaesthesia
temperature measurement
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

Detailed description: The aim of our study is to evaluate the performance of different durations of active preoperative skin-surface warming (prewarming) to prevent perioperative hypothermia in patients undergoing major abdominal surgery under combined general/epidural anaesthesia. The investigators plan to enroll 99 patients in 3 groups. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* planned duration of surgery \> 2 hours
* planned for elective major abdominal surgery under combined epidural/general anaesthesia
* written informed consent
* American society of anesthesiologists status 1-3

Exclusion Criteria:

* duration of surgery \< 90 min
* withdrawal of consent
* emergency surgery

Primary outcomes:
measure: Incidence of hypothermic patients at arrival at PACU
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
city: Pinneberg
country: Germany
facility: Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
name: Jan Hoecker, M.D.
role: STUDY_CHAIR
References:
citation: Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29.
citation: Hocker J, Bein B, Bohm R, Steinfath M, Scholz J, Horn EP. Correlation, accuracy, precision and practicability of perioperative measurement of sublingual temperature in comparison with tympanic membrane temperature in awake and anaesthetised patients. Eur J Anaesthesiol. 2012 Feb;29(2):70-4. doi: 10.1097/EJA.0b013e32834cd6de.
citation: Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.