Impact of Expanded Peri Operative Warming

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Genesys Regional Medical Center
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Tarik Wasfie, MD, Genesys Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01649596
First received: July 23, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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
Hypothermia
Complications
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
Endpoint Classification: Efficacy Study
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 Genesys Regional Medical Center:

Primary Outcome Measures:
  • Incidence of Hypothermic Events [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).


Secondary Outcome Measures:
  • Rate of Complications [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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
Control
Standard of care, warm blankets
Other: Standard of care - warm blankets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649596

Locations
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
3M
Investigators
Principal Investigator: Tarik Wasfie, MD Genesys Regional Medical Center
  More Information

No publications provided

Responsible Party: Tarik Wasfie, MD, MD, General Surgeon, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01649596     History of Changes
Other Study ID Numbers: GRMC120009
Study First Received: July 23, 2012
Last Updated: September 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014