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Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia

NCT01900067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2015-05-06

Study results available
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Summary

The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to Prevent General Anaesthesia Induced Hypothermia During the Perioperative Surgical Period. Null hypothesis (H0): There is no difference between the two study populations (interventional treatment group versus control treatment group) regarding the average of core body temperature measurements during the perioperative phase.Alternative hypothesis (H1): The average of core body temperature measurements during the perioperative phase is significantly higher in the interventional group compared to that of the control group.

Conditions

  • Anesthesia Induced Hypothermia
  • Inadvertent Perioperative Hypothermia

Interventions

DEVICE

BARRIER® EasyWarm Active Self-Warming Blanket

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Alexander Torossian, Prof · Universitätsklinikum Gießen und Marburg

  • Johan Raeder, Prof · OUS-Ullevål

  • Karin Geertsen, Dr · Hallands sjukhus Varberg

  • Bengt Horn af Åminne, Dr · Aleris Specialistvård, Motala

  • Elke Van Gerven, Dr · UZ Leuven Gasthuisberg

  • Marc Van de Velde, Prof. · UZ Leuven Gasthuisberg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900067 on ClinicalTrials.gov