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NCT Number: NCT04177225

Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

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.

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Key information

Conditions

Stroke Volume Variation Diastolic Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Health System

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans thoracic Ultrasound Examination

Procedure

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

Intravenous fluid administration

Other

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

Primary outcomes

  1. Impact of diastolic function on the response threshold for stroke volume variation (SVV) as a predictor of the cardiac output response to fluid administration.

    Time frame: Through study completion, an average of 1 year

    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

Secondary outcomes

  1. Grade assessment of diastolic function

    Time frame: Through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 26, 2019
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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