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CompletedNCT05674916POCUS PATHWAYUpdated Oct 1, 2024

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

An interventional study of Point-of-care ultrasound-driven diagnostic pathway in Dyspnea, sponsored by Aarhus University Hospital. Completed at 9 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
674
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Dyspnea

Keywords

  • Point-of-care Ultrasound
  • Emergency Medicine
  • Diagnostic pathways
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In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 674 is above the median of 48 across 430 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
674 participants (actual)

Study arms

  • Experimental
    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.

    Diagnostic Test: Point-of-care ultrasound-driven diagnostic pathway

  • No intervention
    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.

Interventions

  • Diagnostic testPoint-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.

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What researchers measure

Primary outcomes

  1. 24-hour hospital stay

    Proportion of patients with a hospital lenght-of-stay of less than 24 hours.

    Time frame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 24 hours.

Secondary outcomes

  1. Hospital length-of-stay

    Hospital length-of-stay will secondarily be analyzed using time-to-event analysis.

    Time frame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.

  2. 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.

    Time frame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.

  3. 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.

    Time frame: From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months.

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Study locations

9 sites
  • Herlev Hospital
    Herlev, Capital Denmark Region 2730, Denmark
  • Aarhus University Hospital
    Aarhus, Central Denmark Region 8200, Denmark
  • Gødstrup Regional Hospital
    Gødstrup, Central Denmark Region 7400, Denmark
  • Horsens Regional Hospital
    Horsens, Central Denmark Region 8700, Denmark
  • Viborg Regional Hospital
    Viborg, Central Denmark Region 8800, Denmark
  • University Hospital of Southern Denmark, Esbjerg
    Esbjerg, South Denmark Region 6700, Denmark
  • Odense University Hospital
    Odense, South Denmark Region 5000, Denmark
  • Zealand University Hospital, Køge
    Køge, Zealand Denmark Region 4600, Denmark
  • Slagelse Hospital
    Slagelse, Zealand Denmark Region 4200, Denmark
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References and documents

Related links

Individual participant data

Plan to share: Yes — Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.

Supporting information: Study protocol, Sap, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05674916
Lead sponsor
Aarhus University Hospital
Responsible party
Stig Holm Ovesen (MD, Principal Investigator, Aarhus University Hospital) — Principal investigator
First posted
Jan 9, 2023
Start date
Jan 25, 2023
Primary completion
Aug 24, 2024
Completion
Sep 25, 2024
Last update
Oct 1, 2024

Study contacts

Stig H Ovesen
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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