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Clinical Trials/NCT01671371
NCT01671371
Terminated
Not Applicable

A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope

Yale University1 site in 1 country45 target enrollmentJuly 2012
ConditionsSyncope

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Syncope
Sponsor
Yale University
Enrollment
45
Locations
1
Primary Endpoint
Time to Final Emergency Department Disposition
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Time to Final Emergency Department Disposition

Time Frame: Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)

Secondary Outcomes

  • 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))
  • Information Content provided by Point-of-Care Ultrasound(After performance of point-of-care ultrasound (estimated time frame 1- 6 hours))
  • 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))

Study Sites (1)

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