Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

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

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.

Study Overview

• Status: Completed
• Conditions: Diastolic Dysfunction; Stroke Volume Variation
• Intervention / Treatment: Procedure: Trans thoracic Ultrasound Examination; Other: Intravenous fluid administration

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgical procedures requiring arterial line pressure monitoring at the University of California Davis Medical Center Surgical Unit

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with normal diastolic function; 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; Ultrasound examination of cardiac function before and after induction of general anesthesia.; Other: Intravenous fluid administration; Intravenous fluids will be administered as a bolus in response to standard clinical indications
Patients with abnormal diastolic function; 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; Ultrasound examination of cardiac function before and after induction of general anesthesia.; Other: Intravenous fluid administration; Intravenous fluids will be administered as a bolus in response to standard clinical indications

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Neal Fleming, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1380344

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No