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Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery (THER-6)

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ClinicalTrials.gov Identifier: NCT01795482
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jan Hoecker, University of 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.

Condition or disease Intervention/treatment Phase
Preoperative Warming Prewarming Perioperative Hypothermia General Anaesthesia Epidural Anaesthesia Temperature Monitoring Device: Forced-air warming Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia
Study Start Date : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:
  • Level 1 Snuggle Warm Upper Body Blanket
  • Forced-air warming blower
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:
  • Level 1 Snuggle Warm Upper Body Blanket
  • Forced-air warming blower
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).



Primary Outcome Measures :
  1. Incidence of hypothermic patients at arrival at PACU [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795482


Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
Pinneberg, Schleswig-Holstein, Germany, 25421
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Jan Hoecker, M.D. University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. Jan Hoecker, Associate Professor of Anaesthesiology, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01795482     History of Changes
Other Study ID Numbers: THER-6
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by PD Dr. Jan Hoecker, University of Schleswig-Holstein:
perioperative hypothermia
prewarming
preoperative warming
general anaesthesia
epidural anaesthesia
temperature measurement

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs