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

Coronary Artery Occlusive Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836081
• Other study ID #: 4-2011-0687
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: April 18, 2013
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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%

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Occlusive Disease
• Coronary Disease

Intervention

Other:
• Volume expansion

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measurement of respirophasic carotid flow peak velocity variation before the volume expansion	No