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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742818
• Other study ID #: Forced-air warming in ES
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2019
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Upper body blanket, Bair Hugger
Upper body warming blanket will be used in patients undergoing LEA and EVAR.
• Underbody blanket, Bair Hugger
Underbody warming blanket will be used in patients undergoing LEA and EVAR.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nelson Wolosker

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Gender	The investigators will observe gender distribution in the two groups studied.	At time of surgery ( in minutes)
Secondary	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)
Secondary	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)