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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01671371
Other study ID # 1110009227
Secondary ID
Status Terminated
Phase N/A
First received July 17, 2012
Last updated June 29, 2016
Start date July 2012
Est. completion date July 2013

Study information

Verified date June 2016
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 45
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Yale New Haven Hospital New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Dhatreecharan S, Azar P, Werner MS, et al.

Gabayan GZ, Derose SF, Asch SM, Chiu VY, Glenn SC, Mangione CM, Sun BC. Predictors of short-term (seven-day) cardiac outcomes after emergency department visit for syncope. Am J Cardiol. 2010 Jan 1;105(1):82-6. doi: 10.1016/j.amjcard.2009.08.654. — View Citation

Grossman SA, Fischer C, Lipsitz LA, Mottley L, Sands K, Thompson S, Zimetbaum P, Shapiro NI. Predicting adverse outcomes in syncope. J Emerg Med. 2007 Oct;33(3):233-9. Epub 2007 Jul 5. — View Citation

Keller C, Tristano JM, De Lorenzo R, et al.

Martin NM, Picard MH. Use and appropriateness of transthoracic echocardiography in an academic medical center: a pilot observational study. J Am Soc Echocardiogr. 2009 Jan;22(1):48-52. doi: 10.1016/j.echo.2008.10.003. Epub 2008 Nov 20. — View Citation

Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Short Term Adverse Outcome 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. 7 days from Emergency Department Visit Yes
Primary 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) No
Secondary Time to therapeutic intervention At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours) No
Secondary 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) No
Secondary Number and Type of other imaging studies Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc. End of Emergency Department Encounter (estimated time frame 1- 6 hours) No
Secondary Information Content provided by Point-of-Care Ultrasound calculating from pre and post test probability estimates and the number of diagnoses After performance of point-of-care ultrasound (estimated time frame 1- 6 hours) No
Secondary Number and type of laboratory studies estimated time frame 0-6 hours No
Secondary Number of and time to consultant services Number of consults obtained and the time frame in which the consults were performed estimated time frame (0-6 hours) No
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