Effect of Diastolic Dysfunction on Dynamic Cardiac Monitors

NCT ID: NCT04177225

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-07
• Study Completion Date: 2021-02-01

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.

Conditions

Stroke Volume Variation; Diastolic Dysfunction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Trans thoracic Ultrasound Examination

Intervention Type: PROCEDURE

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

Intravenous fluid administration

Intervention Type: OTHER

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.

Trans thoracic Ultrasound Examination

Intervention Type: PROCEDURE

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

Intravenous fluid administration

Intervention Type: OTHER

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

Interventions

Trans thoracic Ultrasound Examination

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

Intervention Type: PROCEDURE

Intravenous fluid administration

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neal Fleming, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

UC Davis Health System

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40739534 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39075354 (View on PubMed)

Other Identifiers

1380344

Identifier Type: -

Identifier Source: org_study_id