Syncope Clinical Trial
Official title:
A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope
Verified date | June 2016 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Yale New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
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
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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