Back to resultsRespirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
Primary Purpose
Coronary Artery Occlusive Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Volume expansion
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Occlusive Disease focused on measuring fluid responsiveness, carotid artery peak velocity variation, coronary disease
Eligibility Criteria
Inclusion Criteria:
1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery
Exclusion Criteria:
- cardiac rhythm other than sinus
- congestive heart failure
- left ventricular ejection fraction <35%
- history of transient ischemic attack
- pre-existing cerebrovascular disease and peripheral arterial occlusive disease
- presence of carotid artery stenosis >50%
Sites / Locations
- Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fluid responsiveness
Arm Description
Outcomes
Primary Outcome Measures
Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01836081
Brief Title
Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Occlusive Disease
Keywords
fluid responsiveness, carotid artery peak velocity variation, coronary disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fluid responsiveness
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Volume expansion
Other Intervention Name(s)
volume expansion with 6 mL/kg of 6% hydroxylethyl starch 130/0.4
Primary Outcome Measure Information:
Title
Predictive power of the respirophasic carotid flow peak velocity variation for the fluid responsiveness
Description
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.
Time Frame
Measurement of respirophasic carotid flow peak velocity variation before the volume expansion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. patients scheduled for elective isolated off-pump coronary artery bypass graft surgery
Exclusion Criteria:
cardiac rhythm other than sinus
congestive heart failure
left ventricular ejection fraction <35%
history of transient ischemic attack
pre-existing cerebrovascular disease and peripheral arterial occlusive disease
presence of carotid artery stenosis >50%
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24722322
Citation
Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/aeu057. Epub 2014 Apr 9.
Results Reference
derived
Learn more about this trial
Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease
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