Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
1 other identifier
interventional
50
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedResults Posted
Study results publicly available
January 23, 2018
CompletedDecember 30, 2019
December 1, 2019
9 months
March 30, 2016
November 5, 2017
December 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Age ( in Years)
At time of surgery ( in minutes)
Gender
At time of surgery ( in minutes)
Type of Surgery ( LEA and EVAR )
At time of surgery ( in minutes)
Duration of Surgery ( in Minutes)
Across duration of surgery ( in minutes)
Study Arms (2)
Upper body blanket, Bair Hugger
OTHERPatients undergoing EVAR and LEA will use this type of warming blanket.
Underbody blanket, Bair Hugger
OTHERPatients undergoing EVAR and LEA will use this type of warming blanket.
Interventions
Upper body warming blanket will be used in patients undergoing LEA and EVAR.
Underbody warming blanket will be used in patients undergoing LEA and EVAR.
Eligibility Criteria
You may qualify if:
- Patients undergoing LEA and EVAR
- American Society of Anesthesiologists physical status (ASA) : 1-4
You may not qualify if:
- Non-endovascular surgery
- pregnant patients
- patient refusal
- less than 45 minutes duration of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nelson Woloskerlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nelson Wolosker
- Organization
- Hospital Israelita Albert Einstein
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PHD
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 19, 2016
Study Start
September 1, 2014
Primary Completion
June 1, 2015
Study Completion
March 1, 2016
Last Updated
December 30, 2019
Results First Posted
January 23, 2018
Record last verified: 2019-12