Arterial Pressure vs. TE Echo dp/dt

Active, not recruiting

• Conditions: Myocardial Contraction
• Interventions: Device: Concurrent comparison

• Registration Number: NCT04726852
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Study Start: 2021-02-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Concurrent comparison	Patients having elective cardiac surgery

Primary Outcome Measures

Name	Time	Method
dp/dt correlations	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 Outcome Measures

Name	Time	Method
Contractility correlations	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.

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States