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

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Device: Upper body blanket, Bair Hugger; Device: Underbody blanket, Bair Hugger

• Registration Number: NCT02742818
• Lead Sponsor: Nelson Wolosker

Brief Summary

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).

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-06
• Study Completion: 2016-03
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Results First Submitted: 2017-11-05
• Results First Submitted QC: 2017-12-22
• Results First Posted: 2018-01-23
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper body blanket, Bair Hugger	Upper body blanket, Bair Hugger	Patients undergoing EVAR and LEA will use this type of warming blanket.
Underbody blanket, Bair Hugger	Underbody blanket, Bair Hugger	Patients undergoing EVAR and LEA will use this type of warming blanket.

Primary Outcome Measures

Name	Time	Method
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.	Across duration of surgery (up to 210 minutes)	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.

Secondary Outcome Measures

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