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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04177225
Enrollment
120
Registered
2019-11-26
Start date
2019-02-07
Completion date
2021-02-01
Last updated
2021-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Stroke Volume Variation

Brief 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.

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.

Interventions

PROCEDURETrans thoracic Ultrasound Examination

Ultrasound examination of cardiac function before and after induction of general anesthesia.

OTHERIntravenous fluid administration

Intravenous fluids will be administered as a bolus in response to standard clinical indications

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of diastolic function on the response threshold for stroke volume variation (SVV) as a predictor of the cardiac output response to fluid administration.Through study completion, an average of 1 yearThe 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

Secondary

MeasureTime frameDescription
Grade assessment of diastolic functionThrough study completion, an average of 1 yearTransthoracic 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026