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

September 27, 2024 updated by: Stig Holm Ovesen, Aarhus University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

674

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.
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.
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
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.
From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Principal Investigator: Stig H Ovesen, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Actual)

August 24, 2024

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pocuspathway

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.

IPD Sharing Time Frame

There will be no predetermined end date for the data sharing.

IPD Sharing Access Criteria

Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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