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

NCT01795482 | Completed

• 1 other identifier: THER-6
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

perioperative hypothermia; prewarming; preoperative warming; general anaesthesia; epidural anaesthesia; temperature measurement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 2, Prewarming only before general anaesthesia

EXPERIMENTAL

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

Group 3, Prewarming before epidural and general anaesthesia

EXPERIMENTAL

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

Group 1, control group

NO INTERVENTION

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).

Interventions

Forced-air warming DEVICE

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.

Also known as: Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blower

Group 2, Prewarming only before general anaesthesia; Group 3, Prewarming before epidural and general anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (2)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Pinneberg, Schleswig-Holstein, 25421, Germany

Location

Related Publications (3)

• 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.

  PMID: 22376088 BACKGROUND

• 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.

  PMID: 22037543 BACKGROUND

• 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.

  PMID: 26555870 DERIVED

Study Officials

• Jan Hoecker, M.D.

  University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesiology

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

DE (2)