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Impact of Expanded Peri Operative Warming

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ClinicalTrials.gov Identifier: NCT01649596
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Tarik Wasfie, MD, Genesys Regional Medical Center

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.

Condition or disease Intervention/treatment Phase
Hypothermia Complications Device: Warming Gown Other: Standard of care warming Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label.
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Arm Intervention/treatment
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.



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. 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.



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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.

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
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Genesys Regional Medical Center
3M
Investigators
Principal Investigator: Tarik Wasfie, MD Genesys Regional Medical Center

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
Results First Posted: April 5, 2018
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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