Point-Of-Care Ultrasound-Driven vs Standard Diagnostic Pathway in Emergency Department Patients With Dyspnea

Study Overview
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Brief Summary
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The POCUS PATHWAY-trial is a multi-center, randomized, investigator-initiated, open labelled, pragmatic, controlled trial of a point-of-care ultrasound-driven diagnostic pathway vs standard diagnostic pathway in dyspneic emergency department patients. The primary outcome will be 24-hour hospital stay and 642 patients will be included. Key secondary outcomes include overall hospital length of stay, image resources, and 72-hour revisits.

Official Title
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Effect of a Point-Of-Care Ultrasound-Driven vs Standard Diagnostic Pathway on 24-Hour Hospital Stay in Emergency Department Patients With Dyspnea - a Randomized Controlled Trial

Conditions
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Dyspnea

Intervention / Treatment
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* Diagnostic Test: Point-of-care ultrasound-driven diagnostic pathway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency department contact Age ≥ 18 years Chief complaint is Dyspnea Including physician present Exclusion Criteria: Fulfilling of criteria for coded rapid-response teams (i.e., trauma, surgical or medical emergencies). Prior focused lung or focused cardiac ultrasound in the current emergency department stay Prior enrollment in the trial Unable to consent Non Danish-speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-care ultrasound-driven diagnostic pathway<br>The intervention is focused lung and cardiac ultrasound performed as an extension to physical examinations plus diagnostic decision recommendations based on those test results (a point-of-care ultrasound-driven diagnostic pathway). Final decision on next-line imaging and further diagnostic testing should incorporate history and other physical examinations and will remain upon the treating physicians' discretion. | Diagnostic Test: Point-of-care ultrasound-driven diagnostic pathway<br>* Focused lung ultrasound will include 8 zones (anterior and lateral) and evaluate pneumothorax, interstitial syndrome, lung consolidation, and pleural effusion. Focused cardiac ultrasound will include four views (subxiphoid four-chamber view, parasternal long-axis view, parasternal short-axis view, and apical four-chamber view) and evaluate pericardial fluid, right ventricle dilation, and left ventricular systolic contractility.<br>|
| No Intervention: Standard diagnostic pathway<br>Standard diagnostic pathway will include, but not be limited to, blood samples, blood gases, electrocardiogram, and chest x-ray. Focused lung and cardiac ultrasound cannot be performed while the patients stay in the emergency department. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour hospital stay | Proportion of patients with a hospital lenght-of-stay of less than 24 hours. | From date of hospital admission until the date of first documented hospital discharge, assessed up to 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length-of-stay | Hospital length-of-stay will secondarily be analyzed using time-to-event analysis. | From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months. | 
| Image resources | Image resources will be presented as a composite absolute number and incidence proportion counting the cumulative number of participants having received any of the following imaging techniques during the current hospital stay: chest x-rays, echocardiography, computed tomography (CT) angiography, and CT thorax. | From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months. | 
| Number of participants with the composite outcome of 72-hour revisits and overall mortality | 72-hour revisits will be defined as a composite outcome including any unplanned hospital stay within 72 hours from the previous hospital discharge, in-hospital mortality, and mortality within 72 hours from the previous hospital discharge. | From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point-of-care Ultrasound, Emergency Medicine, Diagnostic pathways