Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope

Yale University

Status: Terminated

Conditions: Syncope

Treatments: Other: Point-of-Care Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01671371

1110009227

Details and patient eligibility

About

The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists physicians in the evaluation and management of patients with syncope.

Full description

Syncope is one of the more common presentations to the Emergency Department, representing between 1.2-1.5% of all evaluated patients and up to 6% of admissions. Due to an often broad and overlapping differential diagnosis, syncope represents a disease entity that often requires extensive workup. This typically involves laboratory tests, EKGs, x-rays, computed tomography, or other studies that are costly, time-consuming, and, in the case of diagnostic imaging, frequently involves ionizing radiation. Yet, despite extensive testing, an exact diagnosis is not made in up to 50% of cases.

Cardiac causes of syncope include myocardial infarction, pericardial effusion, volume depletion, arrhythmia, among other entities, many of which are life threatening. Echocardiography (cardiac ultrasound) has been used for inpatient syncope evaluations for several decades. In the Emergency Department, echocardiography is currently being used at the point-of-care (POC) in a limited and focused approach to a variety of conditions. However, POC ultrasound has never been systematically evaluated as a diagnostic or prognostic tool specifically for syncope in the Emergency Department. We aim to determine if an ultrasound-based protocol is effective as an adjunct in the evaluation of syncope. Our research study will examine the utility of POC ultrasound in the diagnosis, imaging and laboratory utilization, and prognosis of syncope in the Emergency Department.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older presenting to the ED with acute syncope (defined as transient loss of consciousness) or near syncope (sensation of impending but not actual loss of consciousness) as a reason for ED visit.

Exclusion criteria

• persistent altered mental status
• alcohol or illicit drug-related loss of consciousness
• definite seizure, and transient loss of consciousness caused by head trauma.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Immediate Ultrasound

Other group

Description:

A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)

Treatment:

Other: Point-of-Care Ultrasound

Delayed Ultrasound

Other group

Description:

A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization

Treatment:

Other: Point-of-Care Ultrasound