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

NCT01671371 | Terminated

• 1 other identifier: 1110009227
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Syncope

Keywords

syncope; point of care; ultrasound; echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Other Outcomes (1)

• Short Term Adverse Outcome

  7 days from Emergency Department Visit

Study Arms (2)

Immediate Ultrasound

OTHER

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

Delayed Ultrasound

OTHER

A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization

Other: Point-of-Care Ultrasound

Interventions

Point-of-Care Ultrasound OTHER

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; Immediate Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• persistent altered mental status
• alcohol or illicit drug-related loss of consciousness
• definite seizure, and transient loss of consciousness caused by head trauma.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

Related Publications (6)

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

  BACKGROUND

• 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. doi: 10.1016/j.jemermed.2007.04.001. Epub 2007 Jul 5.

  PMID: 17976548 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20102895 BACKGROUND

• 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.

  PMID: 19022620 BACKGROUND

• Christopher L Moore and Joshua A Copel.

  BACKGROUND

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard A Taylor, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: August 23, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

US (1)