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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Richard Andrew Taylor, Yale University
ClinicalTrials.gov Identifier:
NCT01671371
First received: July 17, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Syncope
Other: Point-of-Care Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to therapeutic intervention [ Time Frame: At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours) ] [ Designated as safety issue: No ]
  • Time to clinical procedure [ Time Frame: At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours) ] [ Designated as safety issue: No ]
  • Number and Type of other imaging studies [ Time Frame: End of Emergency Department Encounter (estimated time frame 1- 6 hours) ] [ Designated as safety issue: No ]
    Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.

  • Information Content provided by Point-of-Care Ultrasound [ Time Frame: After performance of point-of-care ultrasound (estimated time frame 1- 6 hours) ] [ Designated as safety issue: No ]
    calculating from pre and post test probability estimates and the number of diagnoses

  • Number and type of laboratory studies [ Time Frame: estimated time frame 0-6 hours ] [ Designated as safety issue: No ]
  • Number of and time to consultant services [ Time Frame: estimated time frame (0-6 hours) ] [ Designated as safety issue: No ]
    Number of consults obtained and the time frame in which the consults were performed


Other Outcome Measures:
  • Short Term Adverse Outcome [ Time Frame: 7 days from Emergency Department Visit ] [ Designated as safety issue: Yes ]
    Adverse outcome defined as death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.


Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immediate Ultrasound
A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)
Other: Point-of-Care Ultrasound
Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility
Delayed Ultrasound
A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization
Other: Point-of-Care Ultrasound
Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671371

Contacts
Contact: Richard A Taylor, M.D. 860-402-1276 richard.taylor@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06519
Contact: Taylor       richard.taylor@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Richard A Taylor, M.D. Yale University
  More Information

Publications:
Responsible Party: Richard Andrew Taylor, Assistant Professor of Emergency Medicine, Yale University
ClinicalTrials.gov Identifier: NCT01671371     History of Changes
Other Study ID Numbers: 1110009227
Study First Received: July 17, 2012
Last Updated: August 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
syncope
point of care
ultrasound
echocardiography

Additional relevant MeSH terms:
Syncope
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on November 25, 2014