Impact of Expanded Peri Operative Warming

Hypothermia Clinical Trial

Official title:

Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649596
• Other study ID #: GRMC120009
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: April 4, 2018
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2018
• Source: Genesys Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complications
• Hypothermia

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Genesys Regional Medical Center	Grand Blanc	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Genesys Regional Medical Center	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Hypothermic Events	The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).	12 hours
Secondary	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.	12 hours