Impact of Expanded Peri Operative Warming

Not Applicable

Completed

• Conditions: Complications; Hypothermia
• Interventions: Device: Warming Gown; Other: Standard of care warming

• Registration Number: NCT01649596
• Lead Sponsor: Ascension Health

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-25
• Study Start: 2012-08
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2015-03-12
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-04
• Last Update Submitted: 2018-04-04
• Results First Posted: 2018-04-05
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Subjects are adult patients 18 years and older elective surgery of > 1 hour

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Exclusion Criteria

• Emergency and/or trauma cases
• Patients with diminished mental capacity unable to fill out or respond to survey questions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warming Gown	Warming Gown	Comparison of two types of warming processes prior to, during, and after the surgery procedure.
Standard of Care Warming	Standard of care warming	Standard of care warming with hospital-issued blankets.

Primary Outcome Measures

Name	Time	Method
Incidence of Hypothermic Events	12 hours	The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius).

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	12 hours	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.

Trial Locations

Locations (1)

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States