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

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper body blanket, Bair Hugger
Underbody blanket, Bair Hugger
Sponsored by
Nelson Wolosker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring forced-air warming, hypothermia, endovascular surgery, blanket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Upper body blanket, Bair Hugger

    Underbody blanket, Bair Hugger

    Arm Description

    Patients undergoing EVAR and LEA will use this type of warming blanket.

    Patients undergoing EVAR and LEA will use this type of warming blanket.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 30, 2016
    Last Updated
    December 20, 2019
    Sponsor
    Nelson Wolosker
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02742818
    Brief Title
    Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
    Official Title
    Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nelson Wolosker

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypothermia
    Keywords
    forced-air warming, hypothermia, endovascular surgery, blanket

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Upper body blanket, Bair Hugger
    Arm Type
    Other
    Arm Description
    Patients undergoing EVAR and LEA will use this type of warming blanket.
    Arm Title
    Underbody blanket, Bair Hugger
    Arm Type
    Other
    Arm Description
    Patients undergoing EVAR and LEA will use this type of warming blanket.
    Intervention Type
    Device
    Intervention Name(s)
    Upper body blanket, Bair Hugger
    Intervention Description
    Upper body warming blanket will be used in patients undergoing LEA and EVAR.
    Intervention Type
    Device
    Intervention Name(s)
    Underbody blanket, Bair Hugger
    Intervention Description
    Underbody warming blanket will be used in patients undergoing LEA and EVAR.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    Across duration of surgery (up to 210 minutes)
    Secondary Outcome Measure Information:
    Title
    Age ( in Years)
    Description
    The investigators will observe the profile of the patients and the mean of age in two groups.
    Time Frame
    At time of surgery ( in minutes)
    Title
    Gender
    Description
    The investigators will observe gender distribution in the two groups studied.
    Time Frame
    At time of surgery ( in minutes)
    Title
    Type of Surgery ( LEA and EVAR )
    Description
    The investigators will observe the type of surgery distribution profile in the two groups studied.
    Time Frame
    At time of surgery ( in minutes)
    Title
    Duration of Surgery ( in Minutes)
    Description
    The investigators will observe the duration of surgery (in minutes) in the two groups studied.
    Time Frame
    Across duration of surgery ( in minutes)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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