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

Primary Purpose

Syncope

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point-of-Care Ultrasound
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope focused on measuring syncope, point of care, ultrasound, echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Immediate Ultrasound

Delayed Ultrasound

Arm Description

A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)

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

Outcomes

Primary Outcome Measures

Time to Final Emergency Department Disposition

Secondary Outcome Measures

Time to therapeutic intervention
Time to clinical procedure
Number and Type of other imaging studies
Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.
Information Content provided by Point-of-Care Ultrasound
calculating from pre and post test probability estimates and the number of diagnoses
Number and type of laboratory studies
Number of and time to consultant services
Number of consults obtained and the time frame in which the consults were performed

Full Information

First Posted
July 17, 2012
Last Updated
June 29, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01671371
Brief Title
Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope
Official Title
A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
unable to meet enrollment projections
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
syncope, point of care, ultrasound, echocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Ultrasound
Arm Type
Other
Arm Description
A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)
Arm Title
Delayed Ultrasound
Arm Type
Other
Arm Description
A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization
Intervention Type
Other
Intervention Name(s)
Point-of-Care Ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
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)
Title
Number and Type of other imaging studies
Description
Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.
Time Frame
End of Emergency Department Encounter (estimated time frame 1- 6 hours)
Title
Information Content provided by Point-of-Care Ultrasound
Description
calculating from pre and post test probability estimates and the number of diagnoses
Time Frame
After performance of point-of-care ultrasound (estimated time frame 1- 6 hours)
Title
Number and type of laboratory studies
Time Frame
estimated time frame 0-6 hours
Title
Number of and time to consultant services
Description
Number of consults obtained and the time frame in which the consults were performed
Time Frame
estimated time frame (0-6 hours)
Other Pre-specified Outcome Measures:
Title
Short Term Adverse Outcome
Description
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.
Time Frame
7 days from Emergency Department Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Taylor, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Keller C, Tristano JM, De Lorenzo R, et al.
Results Reference
background
PubMed Identifier
17976548
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. doi: 10.1016/j.jemermed.2007.04.001. Epub 2007 Jul 5.
Results Reference
background
Citation
Dhatreecharan S, Azar P, Werner MS, et al.
Results Reference
background
PubMed Identifier
20102895
Citation
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.
Results Reference
background
PubMed Identifier
19022620
Citation
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.
Results Reference
background
Citation
Christopher L Moore and Joshua A Copel.
Results Reference
background

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

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