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

NCT ID: NCT02206997

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-10-31

Brief Summary

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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

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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).

Conditions

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Hypothermia Hypothermia, Accidental

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Passive Insulation standard treatment

no active warming before start of anesthesia and no active warming at PACU

No interventions assigned to this group

Active prewarming treatment

active warming before start of anesthesia and active warming at PACU following recommendations of S3-guideline

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Jan Hoecker

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan H Hoecker, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

Locations

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FEK Hospital Neumünster

Neumünster, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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THER-GUIDE-EVA

Identifier Type: -

Identifier Source: org_study_id

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