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Impact of Expanded Peri Operative Warming

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01649596
Recruitment Status : Unknown
Verified September 2012 by Tarik Wasfie, MD, Genesys Regional Medical Center.
Recruitment status was:  Recruiting
First Posted : July 25, 2012
Last Update Posted : September 25, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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 or disease Intervention/treatment
Hypothermia Complications Device: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer Other: Standard of care - warm blankets

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


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


Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tarik Wasfie, MD, MD, General Surgeon, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT01649596     History of Changes
Other Study ID Numbers: GRMC120009
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

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