Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Solventum US LLC
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Duration of hypothermia
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Duration of hypothermia
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported