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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bair PawsPatient Adjustable Warming System

Bair PawsPatient Adjustable Warming System for active pre-warming

Group Type OTHER

Bair Paws Patient Adjustable Warming System

Intervention Type DEVICE

Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.

Passive pre-warming

Group Type OTHER

Bair Paws Patient Adjustable Warming System

Intervention Type DEVICE

Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.

Interventions

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Bair Paws Patient Adjustable Warming System

Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.

Intervention Type DEVICE

Other Intervention Names

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Bair Paws Flex Gown

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No