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

NCT ID: NCT02742818

Last Updated: 2019-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Hypothermia

Keywords

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forced-air warming hypothermia endovascular surgery blanket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Upper body blanket, Bair Hugger

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

Group Type OTHER

Upper body blanket, Bair Hugger

Intervention Type DEVICE

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.

Group Type OTHER

Underbody blanket, Bair Hugger

Intervention Type DEVICE

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

Interventions

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Upper body blanket, Bair Hugger

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

Intervention Type DEVICE

Underbody blanket, Bair Hugger

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nelson Wolosker

OTHER

Sponsor Role lead

Responsible Party

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Nelson Wolosker

MD, PHD

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Forced-air warming in ES

Identifier Type: -

Identifier Source: org_study_id