Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

NCT04177225 | Completed

• 1 other identifier: 1380344
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Volume Variation; Diastolic Dysfunction

Outcome Measures

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.

  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 Outcomes (1)

• Grade assessment of diastolic function

  Through study completion, an average of 1 year

Study Arms (2)

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; Other: Intravenous fluid administration

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; Other: Intravenous fluid administration

Interventions

Trans thoracic Ultrasound Examination PROCEDURE

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

Patients with abnormal diastolic function; Patients with normal diastolic function

Intravenous fluid administration OTHER

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

Patients with abnormal diastolic function; Patients with normal diastolic function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health System

Sacramento, California, 95817, United States

Location

Related Publications (2)

• Desai S, Hamilton Z, McCloskey L, Badakhsh O, Li D, Fleming NW. The effect of propofol on the grading of diastolic function: a prospective observational study. BMC Anesthesiol. 2025 Jul 30;25(1):376. doi: 10.1186/s12871-025-03260-2.

  PMID: 40739534 DERIVED

• Abdallah AC, Song SH, Fleming NW. A retrospective study of the effects of a vasopressor bolus on systolic slope (dP/dt) and dynamic arterial elastance (Eadyn). BMC Anesthesiol. 2024 Jul 29;24(1):257. doi: 10.1186/s12871-024-02574-x.

  PMID: 39075354 DERIVED

Study Officials

• Neal Fleming, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: November 26, 2019
• Study Start: February 7, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

US (1)