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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02206997
Other study ID # THER-GUIDE-EVA
Secondary ID
Status Completed
Phase N/A
First received July 30, 2014
Last updated May 1, 2017
Start date February 2014
Est. completion date October 2014

Study information

Verified date May 2017
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 485
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany FEK Hospital Neumünster Neumünster Schleswig-Holstein

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative hypothermia at admission to PACU The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement. admission to PACU
Secondary Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU? admission to PACU
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