Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery

General Anaesthesia Clinical Trial

— THER-6  

Official title:

The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795482
• Other study ID #: THER-6
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: December 15, 2014
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidural Anaesthesia
• General Anaesthesia
• Hypothermia
• Perioperative Hypothermia
• Preoperative Warming
• Prewarming
• Temperature Monitoring

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein
Germany	Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management	Pinneberg	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypothermic patients at arrival at PACU	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.	2 hours	Yes