Impact of Expanded Peri Operative Warming
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Purpose
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.
The study aim is to compare 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.
The overall study goal is to test for differences in the rate of hypothermic events between the two groups.
A secondary goal is 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.
| Condition | Intervention |
|---|---|
|
Hypothermia Complications |
Device: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer Other: Standard of care - warm blankets |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Impact of Expanded Peri Operative Warming for Patients Undergoing Elective Surgery |
- Incidence of Hypothermic Events [ Time Frame: 12 hours ] [ Designated as safety issue: No ]The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).
- Rate of Complications [ Time Frame: 12 hours ] [ Designated as safety issue: No ]Secondary outcome is the rate of surgery complications, hospital length of stay, patient anxiety and patient satisfaction.
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 3M Bair Paws Flex Gown
3M Bair Paws Flex Warming Gown and 3M Bair Paws Model 875 Warming Unit
|
Device: 3M Bair Paws Flex Gown and Bair Paws Model 875 Warmer |
|
Control
Standard of care, warm blankets
|
Other: Standard of care - warm blankets |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Michigan | |
| Genesys Regional Medical Center | Recruiting |
| Grand Blanc, Michigan, United States, 48439 | |
| Contact: Kimberly Barber, PhD 810-606-7724 | |
| Principal Investigator: | Tarik Wasfie, MD | Genesys Regional Medical Center |
More Information
No publications provided
| Responsible Party: | Tarik Wasfie, MD, MD, General Surgeon, Genesys Regional Medical Center |
| ClinicalTrials.gov Identifier: | NCT01649596 History of Changes |
| Other Study ID Numbers: | GRMC120009 |
| Study First Received: | July 23, 2012 |
| Last Updated: | September 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypothermia Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013