CompletedNot Applicable

Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes

Canada220 participantsStarted 2014-09

Plain-language summary

The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets. Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways: * Increased comfort in the pre-operative period by being warmer * Decreased incidence of mild hypothermia * Possible decreased incidence of transfusion with less bleeding * Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU) * Possible shorter stay in the PACU and overall Length of Stay (LOS) * Possible decreased risk for surgical site infection

Who can participate

Age range19 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Elective or "urgent" surgery under general anesthesia * ≥19 years but ≤85 years of age * Able to provide informed consent. Exclusion Criteria: * Refusal of Informed consent * Metabolic derangement/drug therapy already affecting thermal homeostasis * Preexisting hypothermia (\<35.5 degreeC) or hyperthermia (\>37.5 degreeC) (oral) * Surgical procedure anticipated to be longer than 6 hours or less than 1 hour * Emergency (category 1a) Surgery * Patients undergoing exclusively spinal or epidural anesthesia * Patients receiving aortic cross-clamping * Patients receiving transdermal medications

What they're measuring

Duration of hypothermia

Timeframe: Up to 12 hours, until PACU discharge

Trial details

NCT IDNCT02177903

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12