Evaluation of a Patient Warming Concept Following the German S3 Guideline for Prevention of Intraoperative Hypothermia

May 1, 2017 updated by: PD Dr. Jan Hoecker, University Hospital Schleswig-Holstein

Evaluation of a Patient Warming Concept Following the New German Speaking S3 Guideline for Prevention of Intraoperative Hypothermia With Respect to Incidence and Complications of Perioperative Hypothermia

The aim of the study is to evaluate a patient prewarming concept following the recommendations of the S3-guideline "Prevention of perioperative hypothermia" with respect to incidence and complications of perioperative hypothermia. The study hypothesis is that postoperative core temperature in adult patients after prewarming is significantly higher than in patients who were treated following actual standard protocol (passive insulation).

Study Overview

Status

Completed

Detailed Description

The aim of the study is to evaluate a patient prewarming concept following the recommendations of the new german S3-guideline "Prevention of perioperative hypothermia" with respect to incidence and complications of perioperative hypothermia. Prewarming should enable the patients to preserve their core temperature for a longer period and to avoid perioperative hypothermia.The study hypothesis is that postoperative core temperature in adult patients after prewarming is significantly higher than in patients who were treated following the actual standard protocol (passive insulation).

Study Type

Observational

Enrollment (Actual)

485

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Schleswig-Holstein
      • Neumünster, Schleswig-Holstein, Germany, 24534
        • FEK Hospital Neumünster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of FEK Hospital Neumünster scheduled for elective surgery under defined conditions (see below)

Description

Inclusion Criteria:

  • patients scheduled for elective general or orthopedic surgery with expected duration > 45 min
  • American Society of Anesthesiologists physical status 1-3
  • age > 17 years

Exclusion Criteria:

  • emergency surgery
  • patient's denial
  • unexpected decrease of duration of anesthesia < 45 min
  • preoperative body temperature > 38 °C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Passive Insulation standard treatment
no active warming before start of anesthesia and no active warming at PACU
Active prewarming treatment
active warming before start of anesthesia and active warming at PACU following recommendations of S3-guideline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative hypothermia at admission to PACU
Time Frame: admission to PACU
The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement.
admission to PACU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU
Time Frame: admission to PACU
Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU?
admission to PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jan H Hoecker, MD, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THER-GUIDE-EVA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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