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

Not Applicable

Completed

• Conditions: Perioperative Hypothermia; General Anaesthesia; Temperature Monitoring; Prewarming; Preoperative Warming; Epidural Anaesthesia
• Interventions: Device: Forced-air warming

• Registration Number: NCT01795482
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3, Prewarming before epidural and general anaesthesia	Forced-air warming	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).
Group 2, Prewarming only before general anaesthesia	Forced-air warming	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management; 🇩🇪 Pinneberg, Schleswig-Holstein, Germany