Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta

Yale University97 enrolled

Overview

The purpose of this prospective study is to compare point-of-care focused cardiac ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions. We hypothesize that FOCUS will demonstrate good agreement with CTA in the measurement of ascending aortic dimensions and accurately detect dilation and aneurysmal disease.

Nonspecific chest pain is frequently encountered in the emergency department. Accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have good agreement. This studies aims to confirm these findings through prospective evaluation Specific Aims Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions. Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance. Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm. Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference standard.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Aneurysm, Thoracic Aortic Dissection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients aged 18 years and older presenting to the ED for whom a thoracic CTA has been ordered. Exclusion Criteria: * Refusal of verbal consent for ultrasound. * Inability to obtain informed written consent for data collection from either the patient or the patients decision-making surrogate

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS

Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.

Time frame: during emergency department visit (estimated average 3-6 hours)

Secondary Outcomes

Time to Emergency Department Disposition

Time until an admission or discharge order is placed within the electronic medical record

Time frame: estimated time frame 3-6 hours

Number and percent probabilities of differential diagnosis

Number and percent probabilities of differential diagnosis will be obtained before and after ultrasound to calculate the informational content provided by the ultrasound and perform additional uncertainty analyses

Time frame: (estimated time frame 0 -3 hours)

Time to diagnostic imaging

Time when diagnostic imaging is performed

Time frame: estimated time frame 0-6 hours

Data from ClinicalTrials.gov

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