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

Completed

• Conditions: Hypothermia, Accidental; Hypothermia

• Registration Number: NCT02206997
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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).

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative hypothermia at admission to PACU	admission to PACU	The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement.

Secondary Outcome Measures

Name	Time	Method
Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU	admission to PACU	Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU?

Trial Locations

Locations (1)

FEK Hospital Neumünster; 🇩🇪 Neumünster, Schleswig-Holstein, Germany