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Impact of Expanded Peri Operative Warming

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Tarik Wasfie, MD, Genesys Regional Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Tarik Wasfie, MD, Genesys Regional Medical Center Identifier:
First received: July 23, 2012
Last updated: September 24, 2012
Last verified: September 2012

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.

The study aim is to compare 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.

The overall study goal is to test for differences in the rate of hypothermic events between the two groups.

A secondary goal is 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.

Condition Intervention
Device: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer
Other: Standard of care - warm blankets

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery

Resource links provided by NLM:

Further study details as provided by Tarik Wasfie, MD, Genesys Regional Medical Center:

Primary Outcome Measures:
  • Incidence of Hypothermic Events [ Time Frame: 12 hours ]
    The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).

Secondary Outcome Measures:
  • Rate of Complications [ Time Frame: 12 hours ]
    Secondary outcome is the rate of surgery complications, hospital length of stay, patient anxiety and patient satisfaction.

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3M Bair Paws Flex Gown
3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit
Device: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer
Standard of care, warm blankets
Other: Standard of care - warm blankets


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01649596

United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Kimberly Barber, PhD    810-606-7724      
Sponsors and Collaborators
Genesys Regional Medical Center
Principal Investigator: Tarik Wasfie, MD Genesys Regional Medical Center
  More Information

Responsible Party: Tarik Wasfie, MD, MD, General Surgeon, Genesys Regional Medical Center Identifier: NCT01649596     History of Changes
Other Study ID Numbers: GRMC120009
Study First Received: July 23, 2012
Last Updated: September 24, 2012

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms processed this record on May 25, 2017