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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Schleswig-Holstein
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jan Hoecker, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01795482
First received: February 18, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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, in the urinary bladder and sublingually. Shivering will be graded by visual inspection. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.


Condition Intervention
Preoperative Warming
Prewarming
Perioperative Hypothermia
General Anaesthesia
Epidural Anaesthesia
Temperature Monitoring
Device: Forced-air warming

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Incidence of hypothermic patients at arrival at PACU [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of patients with postoperative shivering. [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    After the operation patients will be admitted to the PACU. Here, postoperative shivering will be measured and graded by visual inspection.


Other Outcome Measures:
  • Comparison of sublingual temperature, urinary bladder temperature and tympanic membrane temperature [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    During and after the operation patients' sublingual temperature, urinary bladder temperature and tympanic membrane temperature will be assessed and compared. Correlation, accuracy and precision of these measurements will be evaluated.


Estimated Enrollment: 99
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 2, Prewarming only before general anaesthesia
Active forced-air warming for 20 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 (40°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 20 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 1), for 20 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 3, 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 1, Prewarming before epidural and general anaesthesia
Active forced-air warming for 20 min before start of epidural anaesthesia and for 20 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 (40°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 20 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 1), for 20 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 3, 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 3, 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 (40°C).

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 and postoperative shivering 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, in the urinary bladder and sublingually. Shivering will be graded by visual inspection. Shivering will be graded by visual inspection. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795482

Contacts
Contact: Jan H Hoecker, M.D. +494315972991 hoecker@anaesthesie.uni-kiel.de
Contact: Ernst P Horn, M.D. +494101217226 ernst-peter.horn@sana.de

Locations
Germany
University Hospital Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Jan H Hoecker, M.D.    +94315972991    hoecker@anaesthesie.uni-kiel.de   
Principal Investigator: Jan H Hoecker, M.D.         
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management Recruiting
Pinneberg, Schleswig-Holstein, Germany, 25421
Contact: Ernst P Horn, M.D.    +494101217226    ernst-peter.horn@sana.de   
Principal Investigator: Ernst P Horn, M.D.         
Sub-Investigator: Lisa-Marie Finzelberg, M.S.         
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Berthold Bein, M.D. University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
  More Information

Publications:
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
Study First Received: February 18, 2013
Last Updated: April 14, 2014
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014