Hypothermia
Conditions
Keywords
hypothermia, surgical site infection, opioid usage, blood loss, pain severity, anxiety, Length of Stay
Brief 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
Interventions
DEVICEBair Paws Patient Adjustable Warming System
Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hypothermia | Up to 12 hours, until PACU discharge | The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge. |
Countries
Canada
Outcome results
None listed