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

NCT02861508 | Completed

• 1 other identifier: 1605017729
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Dyspnea; Syncope; Hypotension

Keywords

Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Diagnostic accuracy

  Within 30 days of presentation

• Diagnostic certainty

  Within 2 days of presentation

• Time to disposition

  Within 2 days of presentation

• Total length of stay

  Within 30 days of presentation

• 30-day in-hospital mortality

  Within 30 days of presentation

Other Outcomes (1)

• Return visits with missed diagnosis

  Within 30 days of presentation

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care as determined by treating team. Ultrasound may still be part of the workup per the treating team's discretion.

Other: Usual care

Early POCUS

EXPERIMENTAL

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

Interventions

Point-of-care ultrasound OTHER

Early POCUS

Usual care OTHER

Usual care

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Chest Pain; Dyspnea; Syncope; Hypotension

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher Moore, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: July 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)