- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02206997
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
Conditions
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
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Schleswig-Holstein
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Neumünster, Schleswig-Holstein, Germany, 24534
- FEK Hospital Neumünster
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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 |
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Passive Insulation standard treatment
no active warming before start of anesthesia and no active warming at PACU
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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
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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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