Arterial Pressure vs. TE Echo dp/dt

NCT04726852 | Completed FDA Device

• 1 other identifier: 1655978
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Contraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Contractility correlations

  During the operative period (approximately 5 hours)

Study Arms (1)

Patients

Patients having elective cardiac surgery

Device: Concurrent comparison

Interventions

Concurrent comparison DEVICE

Concurrent comparisons at defined procedure events

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cardiac surgical procedures

You may qualify if:

• 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

You may not qualify if:

• Age \< 18
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (3)

• 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.

  PMID: 2805264 BACKGROUND

• 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.

  PMID: 16750731 BACKGROUND

• 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.

  PMID: 31752966 BACKGROUND

Study Officials

• Neal Fleming, MD, PhD

  UC Davis Schoolo of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 27, 2021
• Study Start: February 2, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Completion of enrollment and data analysis
• Access Criteria: Contact PI

Locations

US (1)