Impact of Expanded Peri Operative Warming

Study Overview
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Brief Summary
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The purpose of this proposed study is to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery.

Detailed Description
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This study was designed to evaluate a normothermia protocol that includes preoperative warming and standard intra operative temperature management in patients undergoing general surgery. It compares short term outcomes in patients for whom warming is expanded by commencing in the pre operative area and is maintained through post operative recovery versus patients receiving the standard warming at time of induction. Patients were randomly assigned to either a warming blanket device or standard warming procedures. The study tested for differences in the rate of hypothermic events between the two groups. A secondary goal was to test for differences in the complication rate and patient satisfaction between the two groups. This study is testing the hypothesis that expanded warming significantly reduces rates of hypothermia and complications over standard warming used only during surgery.

Official Title
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Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery

Conditions
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Hypothermia, Complications

Intervention / Treatment
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* Device: Warming Gown
* Other: Standard of care warming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are adult patients 18 years and older elective surgery of > 1 hour Exclusion Criteria: Emergency and/or trauma cases Patients with diminished mental capacity unable to fill out or respond to survey questions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Warming Gown<br>Comparison of two types of warming processes prior to, during, and after the surgery procedure. | Device: Warming Gown<br>* Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.<br>* Other names: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer;|
| Other: Standard of Care Warming<br>Standard of care warming with hospital-issued blankets. | Other: Standard of care warming<br>* The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypothermic Events | The primary outcome is the incidence of hypothermic events (core <36 degrees celsius). | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared. | 12 hours |