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Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02861508
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : February 28, 2020
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (POCUS) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.

Condition or disease Intervention/treatment Phase
Chest Pain Dyspnea Syncope Hypotension Other: Point-of-care ultrasound Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Impact of Immediate Point-of-Care Ultrasound on Patients With Cardiopulmonary Symptoms in the Emergency Department
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Usual care
Usual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion.
Other: Usual care
Experimental: Early POCUS
Point-of-care ultrasound protocol will involve cardiac views (for pericardial effusion, left ventricular function, left and right ventricular equality, aortic root dilation, and inferior vena cava status), lung views (for pneumothorax, signs of alveolar interstitial syndrome), abdominal views for free fluid, and a view of the abdominal aorta for aneurysm.
Other: Point-of-care ultrasound

Primary Outcome Measures :
  1. Time to appropriate intervention [ Time Frame: Within 30 days of presentation ]
    Based on final diagnosis as determined by final review of the patient's overall visit in the medical record, it will be determined what the appropriate intervention(s) that the patient should have received. Subsequently, the amount of time that elapsed (minutes) between time the patient was roomed in the emergency department (ED) and time to when they received the intervention will be collected. All these time points are readily available in the electronic medical record in the patient care timeline. This outcome will help determine whether early POCUS affects how quickly patients receive appropriate intervention.

Secondary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: Within 30 days of presentation ]
    The treating team in the ED will be asked for their diagnostic impression of the patient's chief complaint at several points during the patient's time in the ED. These points will be (1) after the primary provider's initial assessment, (2) at time of disposition, and (3) if they are in the early POCUS group, after the POCUS findings are relayed to them. They will select their single most likely diagnosis each time, which will be compared against a final diagnosis as determined by final review of the patient's overall visit in the medical record (as this study's gold standard for diagnosis). This outcome will examine how often (percentage-wise) the treating team's diagnosis matches the final diagnosis as well as if early POCUS has any impact on helping physicians reach the correct diagnosis.

  2. Diagnostic certainty [ Time Frame: Within 2 days of presentation ]
    Similar to the outcome of diagnostic accuracy, the treating team in the ED will concomitantly be asked how certain they feel about their diagnosis on a five-point scale. The presence of any changes in certainty (i.e. proportion of patients for whom certainty changed) as well as how much change (e.g. increased certainty by 2 points) will be assessed. This outcome will determine if early POCUS affects physicians' certainty of diagnosis.

  3. Time to disposition [ Time Frame: Within 2 days of presentation ]
    This will be measured as amount of time (in minutes) that elapse between the time patient is roomed in the ED to time the treating team determines patient disposition. These timestamps are available in the medical record under the patient care timeline. This outcome will examine if early POCUS affects the time it takes for the treatment team to achieve a disposition plan for the patient.

  4. Total length of stay [ Time Frame: Within 30 days of presentation ]
    This will be measured as time (in days) between the patient's date of presentation and date of discharge. This outcome will examine if early POCUS affects the amount of time that patients stay in the hospital.

  5. 30-day in-hospital mortality [ Time Frame: Within 30 days of presentation ]
    Patients will be followed in their medical record for up to 30 days after their initial presentation to assess for in-hospital mortality rate. This outcome will examine if early POCUS leads to any significant difference in patient mortality rate compared to usual care.

  6. Duration of POCUS [ Time Frame: Within 2 days of presentation ]
    For the early POCUS group, this will be measured as the amount of time (in minutes) between the time the ultrasound is started and the time the last image is captured. All images/video clips acquired by the ultrasound machine have a timestamp. A blank image will be captured at the start of the exam for the initial timestamp. This outcome will examine how time-consuming our POCUS exam is and provides a sense of how disruptive the introduction of POCUS might be if it were implemented routinely.

Other Outcome Measures:
  1. Return visits with missed diagnosis [ Time Frame: Within 30 days of presentation ]
    The patient's medical record will be followed for 30 days after initial presentation for the presence of any repeat visits with the healthcare system for a similar chief complaint. If so, that repeat visit will be reviewed for the presence of a different diagnosis than that established at the original visit, which would suggest that the correct diagnosis had been missed at that time. It will then be determined what the percentage of patients is with such visits out of all patients in the study. This outcome will examine if POCUS helps with picking up diagnoses that might be missed otherwise.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1)

Exclusion Criteria:

  • <18 years old
  • Prisoner or ward of the state
  • Trauma
  • High acuity requiring treatment in resuscitation room
  • Obvious cause of symptoms (e.g. acute GI bleed causing hypotension)
  • Any form of "do not resuscitate" (DNR) order
  • Roomed in hall of emergency department (location not amenable to ultrasound protocol)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02861508

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United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
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Principal Investigator: Christopher Moore, MD Yale University
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Responsible Party: Yale University Identifier: NCT02861508    
Other Study ID Numbers: 1605017729
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No specific plans for now but would be open to sharing anonymized data.
Keywords provided by Yale University:
Additional relevant MeSH terms:
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Chest Pain
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Neurologic Manifestations
Consciousness Disorders
Neurobehavioral Manifestations
Nervous System Diseases