Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

Study Overview
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Brief Summary
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This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function such as stroke volume variation (SVV) that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction.

Detailed Description
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This investigator initiated, prospective, observational, single-center study is designed to assess whether dynamic monitors of cardiac function, such as stroke volume variation (SVV), that have been shown to predict volume responsiveness differ in clinical utility between patients with and without diastolic dysfunction. Specific Aims: Determine the threshold for the predictive response of SVV with respect to increasing cardiac output for patients with and without diastolic dysfunction. Compare the trans thoracic ultrasound assessment of left ventricular diastolic function before and after the induction of general anesthesia.

Official Title
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Evaluation of Dynamic Monitors for the Prediction of Volume Responsiveness in Patients With and Without Diastolic Dysfunction

Conditions
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Stroke Volume Variation, Diastolic Dysfunction

Intervention / Treatment
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* Procedure: Trans thoracic Ultrasound Examination
* Other: Intravenous fluid administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients Undergoing Elective surgical procedures where invasive arterial line pressure monitoring is a planned part of the intraoperative management Age greater than or equal to 18 Procedures requiring general anesthesia and mechanical ventilation Exclusion Criteria: Adults unable to provide consent Atrial Fibrillation or other significant active arrhythmia Emergency Procedures Hemodynamic instability requiring vasopressor and/or inotropic infusions Presence of an intra-aortic balloon pump Open thoracic procedures Extremes of BMI less than 20 or greater than 40 Pregnancy Prisoners Patient Refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with normal diastolic function<br>Patients undergoing scheduled surgical procedures requiring general anesthesia and invasive arterial pressure and advanced cardiac function monitoring. A trans thoracic ultrasound examination of cardiac function will be performed before induction of general anesthesia . In the operating room, the anesthesia care team will place all of the standard intra-operative monitors and then induce general anesthesia. After induction, the ultrasound examination will be repeated and the planned additional intra-operative monitors will be placed. The arterial catheter will be attached to a FloTrac/EV1000 monitor that will be used to guide fluid management during the procedure. The sensitivity and specificity of SVV to predict the response of cardiac output to intravenous fluid administration will be assessed in this patient group distinguished by their normal left ventricular diastolic function. | Procedure: Trans thoracic Ultrasound Examination<br>* Ultrasound examination of cardiac function before and after induction of general anesthesia.<br>Other: Intravenous fluid administration<br>* Intravenous fluids will be administered as a bolus in response to standard clinical indications<br>|
| Patients with abnormal diastolic function<br>Patients undergoing scheduled surgical procedures requiring general anesthesia and invasive arterial pressure and advanced cardiac function monitoring. A trans thoracic ultrasound examination of cardiac function will be performed before induction of general anesthesia . In the operating room, the anesthesia care team will place all of the standard intra-operative monitors and then induce general anesthesia. After induction, the ultrasound examination will be repeated and the planned additional intra-operative monitors will be placed. The arterial catheter will be attached to a FloTrac/EV1000 monitor that will be used to guide fluid management during the procedure. The sensitivity and specificity of SVV to predict the response of cardiac output to intravenous fluid administration will be assessed in this patient group distinguished by their abnormal left ventricular diastolic function. | Procedure: Trans thoracic Ultrasound Examination<br>* Ultrasound examination of cardiac function before and after induction of general anesthesia.<br>Other: Intravenous fluid administration<br>* Intravenous fluids will be administered as a bolus in response to standard clinical indications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of diastolic function on the response threshold for stroke volume variation (SVV) as a predictor of the cardiac output response to fluid administration. | The sensitivity of SVV as a predictor of the change in cardiac output in response to IV fluid administration will be determined by analysis of the Receiver Operator Characteristic (ROC) curves for each of the patient groups as distinguished by their pre-induction assessment of diastolic left ventricular function | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade assessment of diastolic function | Transthoracic ultrasound will be performed before and after the induction of general anesthesia to assess left ventricular diastolic function. Measurements of trans-mitral flow velocities and tissue Doppler velocities will be used to establish the grade of left ventricular diastolic function. The reproducibility of this measurement before and after the induction of anesthesia has ramifications for intra-operative measurement of diastolic function. | Through study completion, an average of 1 year |