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Completed

NCT Number: NCT02742818

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

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).

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper body blanket, Bair Hugger

Device

Upper body warming blanket will be used in patients undergoing LEA and EVAR.

Underbody blanket, Bair Hugger

Device

Underbody warming blanket will be used in patients undergoing LEA and EVAR.

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.

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nelson Wolosker

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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