Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177225
• Other study ID #: 1380344
• Status: Completed
• Start date: February 7, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Stroke Volume Variation

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis Health System	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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