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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

674 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-25

Study Completion Date

2024-09-25

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.

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Detailed Description

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Conditions

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Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Point-of-care ultrasound-driven diagnostic pathway

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.

Group Type EXPERIMENTAL

Point-of-care ultrasound-driven diagnostic pathway

Intervention Type DIAGNOSTIC_TEST

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.

Standard diagnostic pathway

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Point-of-care ultrasound-driven diagnostic pathway

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Emergency department contact
2. Age ≥ 18 years
3. Chief complaint is Dyspnea
4. Including physician present

Exclusion Criteria

1. Fulfilling of criteria for coded rapid-response teams (i.e., trauma, surgical or medical emergencies).
2. Prior focused lung or focused cardiac ultrasound in the current emergency department stay
3. Prior enrollment in the trial
4. Unable to consent
5. Non Danish-speaking

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No