Impact of Expanded Peri Operative Warming
Primary Purpose
Hypothermia, Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Warming Gown
Standard of care warming
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia
Eligibility 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.
Sites / Locations
- Genesys Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Warming Gown
Standard of Care Warming
Arm Description
Comparison of two types of warming processes prior to, during, and after the surgery procedure.
Standard of care warming with hospital-issued blankets.
Outcomes
Primary Outcome Measures
Incidence of Hypothermic Events
The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).
Secondary Outcome Measures
Patient Satisfaction
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.
Full Information
NCT ID
NCT01649596
First Posted
July 23, 2012
Last Updated
April 4, 2018
Sponsor
Ascension Genesys Hospital
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT01649596
Brief Title
Impact of Expanded Peri Operative Warming
Official Title
Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ascension Genesys Hospital
Collaborators
3M
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label.
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Warming Gown
Arm Type
Active Comparator
Arm Description
Comparison of two types of warming processes prior to, during, and after the surgery procedure.
Arm Title
Standard of Care Warming
Arm Type
Other
Arm Description
Standard of care warming with hospital-issued blankets.
Intervention Type
Device
Intervention Name(s)
Warming Gown
Other Intervention Name(s)
3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer
Intervention Description
Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.
Intervention Type
Other
Intervention Name(s)
Standard of care warming
Intervention Description
The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.
Primary Outcome Measure Information:
Title
Incidence of Hypothermic Events
Description
The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarik Wasfie, MD
Organizational Affiliation
Ascension Genesys Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data was de-identified and not available to share on an individual level. Aggregate data was planned to shared by publishing in a scientific journal.
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Impact of Expanded Peri Operative Warming
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