Internal Jugular Vein Ultrasound Measures and Fluid Responsiveness in Post-Operative Cardiac Surgical Patients
NCT ID: NCT00500981
Last Updated: 2012-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2007-06-30
2008-12-31
Brief Summary
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Detailed Description
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This is a prospective observational study of physiologically-stable, ventilated patients post-cardiac surgery. The primary objective of this study is to evaluate the relationship between the static size of the right IJV and fluid responsiveness in ventilated post-operative cardiac surgical patients. A secondary objective is to evaluate the relationship between dynamic variations in the size of the right IJV related to respiration and leg-raising and fluid responsiveness in the same group. Static and dynamic ultrasound measurements of the right IJV will be performed pre-volume challenge.
Volume responsiveness will be independently assessed by cardiac index measurement before and after rapid infusion of 10% pentastarch. 30 subjects will be recruited pre-operatively and informed consent obtained. Stability of sedation, mechanical ventilation, and hemodynamics will be assured prior to initiation of measurements. Baseline static and respiratory dynamic ultrasound measurements of the right IJV will be obtained and then repeated after bilateral leg-raising. Baseline hemodynamics and cardiac outputs will be obtained using indwelling pulmonary artery catheters. A standardized volume challenge of 10% pentastarch given over 15 minutes will then be provided followed by repeat hemodynamic and cardiac output measurements.
Offline measurements of IJV size will be obtained from unmodified stored video loops by a single observer blinded to patient identity, hemodynamic, and fluid response data. Fluid responsiveness will be assessed by examining the change in cardiac index after volume challenge with a fluid responsive state defined as an increase of ≥ 12 % of cardiac index after volume challenge. The relationship between volume responsiveness and IJ ultrasound measures will be evaluated continuously and dichotomously.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Intravenous fluid bolus
Administration of 500 ml of 10% pentastarch
Volume challenge
Ultrasound evaluation of internal jugular vein
Interventions
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Volume challenge
Ultrasound evaluation of internal jugular vein
Eligibility Criteria
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Inclusion Criteria
* Able to provide advanced informed consent
* Planned elective or semi-urgent cardiac surgery
Exclusion Criteria
* Congenital heart disease associated with cardiac shunting
* Pre or post-operative presence of an intra-aortic balloon pump
* Severe chronic obstructive pulmonary disease
* Hemodynamic instability such that inotropes/vasopressor dosing is not constant
* Respiratory instability and/or need for PEEP \> 5 cmH20
18 Years
ALL
No
Sponsors
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Department of Critical Care Medicine
UNKNOWN
University of Calgary
OTHER
Responsible Party
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Dr. Dan Zuege
Clinical Associate Professor of Medicine
Principal Investigators
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Dan Zuege, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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Other Identifiers
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20855
Identifier Type: -
Identifier Source: org_study_id