Impact of Expanded Peri Operative Warming

Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Complications
• Intervention / Treatment: Device: Warming Gown; Other: Standard of care warming

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital
• Collaborators: 3M
• Investigators: Principal Investigator: Tarik Wasfie, MD, Ascension Genesys Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: GRMC120009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data was de-identified and not available to share on an individual level. Aggregate data was planned to shared by publishing in a scientific journal.