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

Primary Purpose

Preoperative Warming, Prewarming, Perioperative Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Forced-air warming
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preoperative Warming focused on measuring perioperative hypothermia, prewarming, preoperative warming, general anaesthesia, epidural anaesthesia, temperature measurement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Schleswig-Holstein, Campus Kiel
  • Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group 2, Prewarming only before general anaesthesia

Group 3, Prewarming before epidural and general anaesthesia

Group 1, control group

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2013
Last Updated
December 15, 2014
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT01795482
Brief Title
Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Warming, Prewarming, Perioperative Hypothermia, General Anaesthesia, Epidural Anaesthesia, Temperature Monitoring
Keywords
perioperative hypothermia, prewarming, preoperative warming, general anaesthesia, epidural anaesthesia, temperature measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2, Prewarming only before general anaesthesia
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 3, Prewarming before epidural and general anaesthesia
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 1, control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Forced-air warming
Other Intervention Name(s)
Level 1 Snuggle Warm Upper Body Blanket, Forced-air warming blower
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of hypothermic patients at arrival at PACU
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hoecker, M.D.
Organizational Affiliation
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
City
Pinneberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
25421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22376088
Citation
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.
Results Reference
background
PubMed Identifier
22037543
Citation
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.
Results Reference
background
PubMed Identifier
26555870
Citation
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.
Results Reference
derived

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

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