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Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01836081
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
12
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate usefulness of the respirophasic variation in carotid artery peak flow velocity measured by Doppler ultrasound, which is noninvasive and easily accessible, as a predictor of fluid responsiveness in patients with coronary artery disease.

Condition or Disease Intervention/Treatment Phase
  • Other: Volume expansion
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: fluid responsiveness

Other: Volume expansion
Other Names:
  • volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness [Measurement of respirophasic carotid flow peak velocity variation before the volume expansion]

      After induction of anesthesia, peak velocity of carotid artery blood flow is measured by the pulsed wave Doppler signal obtained from the left common carotid artery. Respirophasic variation of the peak velocity is defined as the difference between the maximum and the minimum values of peak velocity divided by the mean of the two values during one respiratory cycle. Fluid responder is defined as a patient whose stroke volume index is increased ≥15% after volume expansion. The receiver operating characteristic curve analysis to descriminiate fluid responder is performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery
    Exclusion Criteria:

    1. cardiac rhythm other than sinus

    2. congestive heart failure

    3. left ventricular ejection fraction <35%

    4. history of transient ischemic attack

    5. pre-existing cerebrovascular disease and peripheral arterial occlusive disease

    6. presence of carotid artery stenosis >50%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University College of Medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01836081
    Other Study ID Numbers:
    • 4-2011-0687
    First Posted:
    Apr 19, 2013
    Last Update Posted:
    Apr 19, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Yonsei University
    fluid responsiveness
    carotid artery peak velocity variation
    coronary disease
    Additional relevant MeSH terms:
    Coronary Disease

    Study Results

    No Results Posted as of Apr 19, 2013