Clinical trial NCT05674916: Point-Of-Care Ultrasound-Driven vs Standard Diagnostic Pathway in Emergency Department Patients With Dyspnea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Keywords: Point-of-care Ultrasound
Emergency Medicine
Diagnostic pathways
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 24-hour hospital stay
timeFrame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 24 hours.
Secondary outcomes:
measure: Hospital length-of-stay
timeFrame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.
measure: Image resources
timeFrame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.
measure: Number of participants with the composite outcome of 72-hour revisits and overall mortality
timeFrame: From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Capital Denmark Region
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Gødstrup
country: Denmark
facility: Gødstrup Regional Hospital
state: Central Denmark Region
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
state: Central Denmark Region
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
state: Central Denmark Region
city: Esbjerg
country: Denmark
facility: University Hospital of Southern Denmark, Esbjerg
state: South Denmark Region
city: Odense
country: Denmark
facility: Odense University Hospital
state: South Denmark Region
city: Køge
country: Denmark
facility: Zealand University Hospital, Køge
state: Zealand Denmark Region
city: Slagelse
country: Denmark
facility: Slagelse Hospital
state: Zealand Denmark Region
Study officials:
affiliation: Aarhus University Hospital
name: Stig H Ovesen
role: PRINCIPAL_INVESTIGATOR
References: