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

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Device: Bair Paws Patient Adjustable Warming System

• Registration Number: NCT02177903
• Lead Sponsor: Solventum US LLC

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bair PawsPatient Adjustable Warming System	Bair Paws Patient Adjustable Warming System	Bair PawsPatient Adjustable Warming System for active pre-warming
Passive pre-warming	Bair Paws Patient Adjustable Warming System	Passive pre-warming

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Royal Columbian Hospital; 🇨🇦 Vancouver, British Columbia, Canada