THER-6: Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 2, Prewarming only before general anaesthesia Active forced-air warming for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
Device: Forced-air warming
In the intervention groups a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the patients sitting or laying on the operating table for 15 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 3), for 15 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 1, control). All patients will receive forced-air warming after induction of general anaesthesia till end of surgery.
Other Names:
|
| Experimental: Group 3, Prewarming before epidural and general anaesthesia Active forced-air warming for 15 min before start of epidural anaesthesia and for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
Device: Forced-air warming
In the intervention groups a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the patients sitting or laying on the operating table for 15 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 3), for 15 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 1, control). All patients will receive forced-air warming after induction of general anaesthesia till end of surgery.
Other Names:
|
| No Intervention: Group 1, control group No active warming before start of epidural or general anaesthesia, active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C). |
Outcome Measures
Primary Outcome Measures
- Incidence of hypothermic patients at arrival at PACU [2 hours]
After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature < 36°C)will be measured.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Schleswig-Holstein, Campus Kiel | Kiel | Schleswig-Holstein | Germany | 24105 |
| 2 | Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management | Pinneberg | Schleswig-Holstein | Germany | 25421 |
Sponsors and Collaborators
- University Hospital Schleswig-Holstein
Investigators
- Study Chair: Jan Hoecker, M.D., University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- Höcker J, Bein B, Böhm 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.
- Horn EP, Bein B, Böhm R, Steinfath M, Sahili N, Höcker 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.
- THER-6