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

Dyspnea Clinical Trial

— POCUS PATHWAY  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674916
• Other study ID #: pocuspathway
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: February 25, 2025

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: Stig H Ovesen
• Phone: +4527121505
• Email: stigholm[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 674
• Est. completion date: February 25, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Emergencies

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Denmark Region
Denmark	University Hospital of Southern Denmark, Esbjerg	Esbjerg	South Denmark Region
Denmark	Gødstrup Regional Hospital	Gødstrup	Central Denmark Region
Denmark	Herlev Hospital	Herlev	Capital Denmark Region
Denmark	Horsens Regional Hospital	Horsens	Central Denmark Region
Denmark	Zealand University Hospital, Køge	Køge	Zealand Denmark Region
Denmark	Odense University Hospital	Odense	South Denmark Region
Denmark	Slagelse Hospital	Slagelse	Zealand Denmark Region
Denmark	Viborg Regional Hospital	Viborg	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.

External Links

•   Trial website