Clinical trial NCT04726852: Arterial Pressure vs. TE Echo dp/dt
Official title: Comparison of Arterial Pressure Waveform Derived dp/dt Versus Transesophageal Echocardiogram Derived Left Ventricular dp/dt Max in the Intra-operative Setting
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocardial Contraction
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgical procedures

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.

Eligibility criteria: 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

Primary outcomes:
measure: dp/dt correlations
timeFrame: During the operative period (approximately 5 hours)
Secondary outcomes:
measure: Contractility correlations
timeFrame: During the operative period (approximately 5 hours)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis Schoolo of Medicine
name: Neal Fleming, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.