Arterial Pressure vs. TE Echo dp/dt

Comparison of Arterial Pressure Waveform Derived dp/dt Versus Transesophageal Echocardiogram Derived Left Ventricular dp/dt Max in the Intra-operative Setting

This study seeks to assess the strength of correlation between arterial pressure waveform derived contractility as quantified by the maximal rate of pressure change ans a function of time (dp/dtmax) and transesophageal echocardiographically (TEE) determined contractility, also quantified by dp/dtmax. In addition, correlations between dp/dtmax. In addition, TEE derived assessment of ejection fraction will provide guidance for relating this new parameter with other standard contractility assessments.

Study Overview

• Status: Completed
• Conditions: Myocardial Contraction
• Intervention / Treatment: Device: Concurrent comparison

Detailed Description

The Hypotension Prediction Index (HPI, Edwards LifeScience, Irvine, CA) software is a new technology that integrates selected dynamic cardiovascular measurements, using the arterial pressure waveform, to predict impending intra-operative hypotensive episodes. In addition, the monitor provides a calculated (dp/dtmax), determined from the radial arterial pressure waveform as a guide to optimal therapeutic interventions. A recent study has demonstrated significant correlation between radial arterial dp/dtmax values calculated with the HPI software to those calculated using echocardiography in patients with acute heart failure in the cardiac ICU setting, especially in those with higher systemic vascular resistance, lower cardiac output, and lower stroke volumes.

This study seeks to assess the strength of these correlations in the intra-operative setting in patients with normal and abnormal cardiac function. Corroboration of the reliability of this newer method of ascertaining Left ventricular contractility and quantifying the correlations in different settings will allow for more accurate and efficient clinical utilization of dp/dtmax in a larger number of clinical settings.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cardiac surgical procedures

Description

Inclusion Criteria:

• Patients undergoing elective cardiac surgical procedures where invasive arterial pressure monitoring and intra-operative transesophageal echocardiography are planned parts of the intra-operative management.
• Age ≥ 18

Exclusion Criteria:

• Age < 18
• Pregnant women
• Prisoners

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients having elective cardiac surgery	Device: Concurrent comparison; Concurrent comparisons at defined procedure events

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dp/dt correlations	The correlation between dp/dtmax as calculated by the Hypotension Prediction Index (HPI) software and dp/dtmax as calculated by TEE mitral regurgitation jet analysis.	During the operative period (approximately 5 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contractility correlations	Determine the correlation between dp/dtmax and standard methods of 2-dimensional and 3-dimensional left ventricular ejection fraction measurements.	During the operative period (approximately 5 hours)

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Neal Fleming, MD, PhD, UC Davis Schoolo of Medicine

Publications and helpful links

General Publications

• Bargiggia GS, Bertucci C, Recusani F, Raisaro A, de Servi S, Valdes-Cruz LM, Sahn DJ, Tronconi L. A new method for estimating left ventricular dP/dt by continuous wave Doppler-echocardiography. Validation studies at cardiac catheterization. Circulation. 1989 Nov;80(5):1287-92. doi: 10.1161/01.cir.80.5.1287.
• De Hert SG, Robert D, Cromheecke S, Michard F, Nijs J, Rodrigus IE. Evaluation of left ventricular function in anesthetized patients using femoral artery dP/dt(max). J Cardiothorac Vasc Anesth. 2006 Jun;20(3):325-30. doi: 10.1053/j.jvca.2005.11.006. Epub 2006 Feb 21.
• Ostadal P, Vondrakova D, Kruger A, Janotka M, Naar J. Continual measurement of arterial dP/dtmax enables minimally invasive monitoring of left ventricular contractility in patients with acute heart failure. Crit Care. 2019 Nov 21;23(1):364. doi: 10.1186/s13054-019-2654-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1655978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected de-identified patient data
• IPD Sharing Time Frame: Completion of enrollment and data analysis
• IPD Sharing Access Criteria: Contact PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No