Arterial Pressure vs. TE Echo dp/dt

NCT ID: NCT04726852

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-02

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Contraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients having elective cardiac surgery

Concurrent comparison

Intervention Type DEVICE

Concurrent comparisons at defined procedure events

Interventions

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Concurrent comparison

Concurrent comparisons at defined procedure events

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Fleming, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Davis Schoolo of Medicine

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 2805264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16750731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31752966 (View on PubMed)

Other Identifiers

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1655978

Identifier Type: -

Identifier Source: org_study_id

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