- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351036
Evaluation of the S3 Guideline on Avoidance of Perioperative Hypothermia - Already a Standard or Wishful Thinking?
November 18, 2017 updated by: Timo Iden, University Hospital Schleswig-Holstein
Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events.
The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia concerning it´s implementation in the clinical routine.
Study Overview
Status
Withdrawn
Detailed Description
Perioperative hypothermia is a common problem in today´s surgical and anesthesiological patient care and is associated with many adverse events such as impaired coagulation, increased risk for wound infections and patient discomfort among others.
The intention of this study was to evaluate the current S3 guideline on the avoidance of perioperative hypothermia published in 2014 concerning it´s implementation in the clinical routine.
In a first phase the current status should be recorded.
If this reveals an inappropriate high incidence of perioperative hypothermia training arrangements shall be taken for non-physician personnel in the PACU in a 2nd phase of the project.
The third phase is intended to evaluate the effect of the training arrangements on the incidence of hypothermia.
Study Type
Observational
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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Kiel, Schleswig-Holstein, Germany, 24105
- University Hospital Schleswig-Holstein, Campus Kiel
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients ≥ 18 years undergoing elective surgery
Description
Inclusion Criteria:
- Patients ≥ 18 years undergoing elective surgery admitted to the PACU
Exclusion Criteria:
- Patients < 18 years
- Emergency surgery
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative hypothermia
Time Frame: Immediately after arrival at PACU
|
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
|
Immediately after arrival at PACU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of intraoperative hypothermia
Time Frame: Duration of surgical procedure
|
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
|
Duration of surgical procedure
|
|
Incidence of preoperative hypothermia
Time Frame: Immediately after arrival at holding area
|
Evaluation of the S3 guideline on avoidance of perioperative hypothermia
|
Immediately after arrival at holding area
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jan Höcker, MD, Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Helpful Links
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
April 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
December 7, 2015
First Submitted That Met QC Criteria
November 18, 2017
First Posted (Actual)
November 22, 2017
Study Record Updates
Last Update Posted (Actual)
November 22, 2017
Last Update Submitted That Met QC Criteria
November 18, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S3_Evaluation_Hypothermia
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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