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

Molnlycke Health Care AB · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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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.
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