End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness

Study Overview
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Brief Summary
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The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

Detailed Description
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Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Official Title
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End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Diagnostic Test: EEO and EIO test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cardiac surgical patients hypotension after induction of anesthesia required volume expansion by clinical judgement of the anesthesiologist Exclusion Criteria: younger than 18 years severe valve regurgitation or systolic dysfunction of the right ventricle contraindication of the transesophageal echocardiography examination cardiac arrhythmia left ventricular ejection fraction less than 30% before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEO and EIO test<br>velocity time integral of the aorta measured by transesophageal echocardiography during end expiratory and end inspiratory occlusion test to predict volume responsiveness.Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution. | Diagnostic Test: EEO and EIO test<br>* velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responders | responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid | within 1 minute after volume expansion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nonresponders | nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid | within 1 minute after volume expansion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-expiratory occlusion test, end-inspiratory occlusion test, transesophageal echocardiography, passive legs raising, fluid challenge