Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models

Prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (LEA) and endovascular abdominal aortic aneurysm repair (EVAR).

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Device: Upper body blanket, Bair Hugger; Device: Underbody blanket, Bair Hugger

Detailed Description

Fifty patients undergoing LEA and EVAR will be randomized into two groups: Group upper body blanket and Group underbody blanket. All patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. The warming unit used (Bair Hugger 750 warming unit, Arizant Healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (Bair Hugger 522 upper body blanket, 3M) and underbody blanket (Bair Hugger 635 full acess underbody blanket, 3M). Surgical and anesthetic complications will be noted. Only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing LEA and EVAR
• American Society of Anesthesiologists physical status (ASA) : 1-4

Exclusion Criteria:

• Non-endovascular surgery
• pregnant patients
• patient refusal
• less than 45 minutes duration of surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Upper body blanket, Bair Hugger; Patients undergoing EVAR and LEA will use this type of warming blanket.	Device: Upper body blanket, Bair Hugger; Upper body warming blanket will be used in patients undergoing LEA and EVAR.
Other: Underbody blanket, Bair Hugger; Patients undergoing EVAR and LEA will use this type of warming blanket.	Device: Underbody blanket, Bair Hugger; Underbody warming blanket will be used in patients undergoing LEA and EVAR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.	After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.	Across duration of surgery (up to 210 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age ( in Years)	The investigators will observe the profile of the patients and the mean of age in two groups.	At time of surgery ( in minutes)
Gender	The investigators will observe gender distribution in the two groups studied.	At time of surgery ( in minutes)
Type of Surgery ( LEA and EVAR )	The investigators will observe the type of surgery distribution profile in the two groups studied.	At time of surgery ( in minutes)
Duration of Surgery ( in Minutes)	The investigators will observe the duration of surgery (in minutes) in the two groups studied.	Across duration of surgery ( in minutes)

Collaborators and Investigators

• Sponsor: Nelson Wolosker

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: hypothermia; forced-air warming; endovascular surgery; blanket
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: Forced-air warming in ES