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

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ClinicalTrials.gov Identifier: NCT02742818
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : January 23, 2018
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Nelson Wolosker, Hospital Israelita Albert Einstein

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hypothermia Device: Upper body blanket, Bair Hugger Device: Underbody blanket, Bair Hugger Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 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 :
  1. Age ( in Years) [ Time Frame: At time of surgery ( in minutes) ]
    The investigators will observe the profile of the patients and the mean of age in two groups.

  2. Gender [ Time Frame: At time of surgery ( in minutes) ]
    The investigators will observe gender distribution in the two groups studied.

  3. Type of Surgery ( LEA and EVAR ) [ Time Frame: At time of surgery ( in minutes) ]
    The investigators will observe the type of surgery distribution profile in the two groups studied.

  4. Duration of Surgery ( in Minutes) [ Time Frame: Across duration of surgery ( in minutes) ]
    The investigators will observe the duration of surgery (in minutes) in the two groups studied.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Nelson Wolosker, MD, PHD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT02742818    
Other Study ID Numbers: Forced-air warming in ES
First Posted: April 19, 2016    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: December 30, 2019
Last Verified: December 2019
Keywords provided by Nelson Wolosker, Hospital Israelita Albert Einstein:
forced-air warming
hypothermia
endovascular surgery
blanket
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes