Impact of Expanded Peri Operative Warming

NCT01649596 | Completed Results DMC

• 1 other identifier: GRMC120009
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypothermic Events

  The primary outcome is the incidence of hypothermic events (core \<36 degrees celsius).

  12 hours

Secondary Outcomes (1)

• Patient Satisfaction

  12 hours

Study Arms (2)

Warming Gown

ACTIVE COMPARATOR

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

Device: Warming Gown

Standard of Care Warming

OTHER

Standard of care warming with hospital-issued blankets.

Other: Standard of care warming

Interventions

Warming Gown DEVICE

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

Also known as: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer

Warming Gown

Standard of care warming 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.

Standard of Care Warming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are adult patients 18 years and older elective surgery of \> 1 hour

You may not qualify if:

• Emergency and/or trauma cases
• Patients with diminished mental capacity unable to fill out or respond to survey questions.

Sponsors & Collaborators

• Ascension Health: lead
• 3M: collaborator

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Surgeon
• Organization: Genesys Regional Medical Center

twasfie@gmail.com

810-606-6500

Study Officials

• Tarik Wasfie, MD

  Ascension Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, General Surgeon

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 5, 2018
• Results First Posted: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)