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

Solventum US LLC

Status: Completed

Conditions: Hypothermia

Treatments: Device: Bair Paws Patient Adjustable Warming System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177903

EM-05-013093

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups

Bair PawsPatient Adjustable Warming System

Other group

Description:

Bair PawsPatient Adjustable Warming System for active pre-warming

Treatment:

Device: Bair Paws Patient Adjustable Warming System

Passive pre-warming

Other group

Description:

Passive pre-warming

Treatment:

Device: Bair Paws Patient Adjustable Warming System