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

Not Applicable

Terminated

• Conditions: Syncope
• Interventions: Other: Point-of-Care Ultrasound

• Registration Number: NCT01671371
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-23
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Ultrasound	Point-of-Care Ultrasound	A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)
Delayed Ultrasound	Point-of-Care Ultrasound	A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization

Primary Outcome Measures

Name	Time	Method
Time to Final Emergency Department Disposition	Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)

Secondary Outcome Measures

Name	Time	Method
Time to therapeutic intervention	At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours)
Time to clinical procedure	At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours)
Number and Type of other imaging studies	End of Emergency Department Encounter (estimated time frame 1- 6 hours)	Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.
Information Content provided by Point-of-Care Ultrasound	After performance of point-of-care ultrasound (estimated time frame 1- 6 hours)	calculating from pre and post test probability estimates and the number of diagnoses
Number and type of laboratory studies	estimated time frame 0-6 hours
Number of and time to consultant services	estimated time frame (0-6 hours)	Number of consults obtained and the time frame in which the consults were performed

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States