At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Perioperative Core Body Temperature When Using Forced Air Warming or BARRIER® EasyWarm to Prevent Inadvertent Perioperative Hypothermia: An Open-label, Randomized Non-inferiority Comparison
In Brief
A clinical study evaluating Active self warming blanket and Forced air warming device for Inadvertent Perioperative Hypothermia and Preoperative Anxiety Experienced by the Patient. Completed, enrolled 55 participants across 3 sites in 3 countries.
Detailed Summary
This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively. A non-inferiority, prospective, open-labelled, randomized, parallel investigation. Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia. The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups. A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.
Study Details
Timeline
Interventions
BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.