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

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT02206997
Collaborator
(none)
485
Enrollment
1
Location
8
Duration (Months)
61
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    485 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Feb 1, 2014
    Actual Primary Completion Date :
    Oct 1, 2014
    Actual Study Completion Date :
    Oct 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Passive Insulation standard treatment

    no active warming before start of anesthesia and no active warming at PACU
    Active prewarming treatment

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 FEK Hospital Neumünster Neumünster Schleswig-Holstein Germany 24534

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    • Principal Investigator: Jan H Hoecker, MD, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PD Dr. Jan Hoecker, MD, University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT02206997
    Other Study ID Numbers:
    • THER-GUIDE-EVA
    First Posted:
    Aug 1, 2014
    Last Update Posted:
    May 4, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by PD Dr. Jan Hoecker, MD, University Hospital Schleswig-Holstein
    perioperative hypothermia
    prewarming
    treatment guideline
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of May 4, 2017