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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206997
• Other study ID #: THER-GUIDE-EVA
• 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
• 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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Accidental

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