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OpenTrials
Completed

NCT Number: NCT04726852

Arterial Pressure vs. TE Echo dp/dt

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Concurrent comparison

Device

Concurrent comparisons at defined procedure events

Primary outcomes

  1. dp/dt correlations

    Time frame: During the operative period (approximately 5 hours)

    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.

Secondary outcomes

  1. Contractility correlations

    Time frame: During the operative period (approximately 5 hours)

    Determine the correlation between dp/dtmax and standard methods of 2-dimensional and 3-dimensional left ventricular ejection fraction measurements.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2021
Registry last updated
Sep 18, 2025

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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