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Completed

NCT Number: NCT05674916

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

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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Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Herlev, Capital Denmark Region, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point-of-care ultrasound-driven diagnostic pathway

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.

Primary outcomes

  1. 24-hour hospital stay

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

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

Secondary outcomes

  1. Hospital length-of-stay

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

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

  2. Image resources

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

    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.

  3. Number of participants with the composite outcome of 72-hour revisits and overall mortality

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

    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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Acronym: POCUS PATHWAY

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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