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

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain; Syncope; Hypotension; Dyspnea
• Intervention / Treatment: Other: Usual care; Other: Point-of-care ultrasound

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to appropriate intervention	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.	Within 30 days of presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	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.	Within 30 days of presentation
Diagnostic certainty	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.	Within 2 days of presentation
Time to disposition	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.	Within 2 days of presentation
Total length of stay	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.	Within 30 days of presentation
30-day in-hospital mortality	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.	Within 30 days of presentation
Duration of POCUS	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.	Within 2 days of presentation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return visits with missed diagnosis	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.	Within 30 days of presentation

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Christopher Moore, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 5, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasonography
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Signs and Symptoms, Respiratory; Unconsciousness; Consciousness Disorders; Emergencies; Chest Pain; Hypotension; Syncope; Dyspnea
• Other Study ID Numbers: 1605017729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No specific plans for now but would be open to sharing anonymized data.