Impact of Expanded Peri Operative Warming
Recruitment status was Recruiting
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.
Device: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer
Other: Standard of care - warm blankets
|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|
- 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).
- 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.
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649596
|United States, Michigan|
|Genesys Regional Medical Center||Recruiting|
|Grand Blanc, Michigan, United States, 48439|
|Contact: Kimberly Barber, PhD 810-606-7724|
|Principal Investigator:||Tarik Wasfie, MD||Genesys Regional Medical Center|