Impact of Expanded Peri Operative Warming

NCT ID: NCT01649596

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-04-30

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.

Conditions

Hypothermia; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Warming Gown

Comparison of two types of warming processes prior to, during, and after the surgery procedure.

Group Type: ACTIVE_COMPARATOR

Warming Gown

Intervention Type: DEVICE

Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.

Standard of Care Warming

Standard of care warming with hospital-issued blankets.

Group Type: OTHER

Standard of care warming

Intervention Type: OTHER

The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.

Interventions

Warming Gown

Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

Ascension Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Tarik Wasfie, MD

MD, General Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarik Wasfie, MD

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Locations

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Countries

United States

Other Identifiers

GRMC120009

Identifier Type: -

Identifier Source: org_study_id