Impact of Expanded Peri Operative Warming
|ClinicalTrials.gov Identifier: NCT01649596|
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia Complications||Device: Warming Gown Other: Standard of care warming||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label.|
|Official Title:||Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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 Name: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer
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.
- Incidence of Hypothermic Events [ Time Frame: 12 hours ]The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).
- Patient Satisfaction [ Time Frame: 12 hours ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649596
|United States, Michigan|
|Genesys Regional Medical Center|
|Grand Blanc, Michigan, United States, 48439|
|Principal Investigator:||Tarik Wasfie, MD||Genesys Regional Medical Center|