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

NCT ID: NCT01795482

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Preoperative Warming Prewarming Perioperative Hypothermia General Anaesthesia Epidural Anaesthesia Temperature Monitoring

Keywords

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perioperative hypothermia prewarming preoperative warming general anaesthesia epidural anaesthesia temperature measurement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Forced-air warming

Intervention Type 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.

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).

Group Type EXPERIMENTAL

Forced-air warming

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Level 1 Snuggle Warm Upper Body Blanket Forced-air warming blower

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Jan Hoecker

Associate Professor of Anaesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Hoecker, M.D.

Role: STUDY_CHAIR

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

Locations

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University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management

Pinneberg, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 22376088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22037543 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26555870 (View on PubMed)

Other Identifiers

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THER-6

Identifier Type: -

Identifier Source: org_study_id