DyspneaPOCUS PATHWAYNCT05674916
Point-Of-Care Ultrasound-Driven vs Standard Diagnostic Pathway in Emergency Department Patients With Dyspnea
A study testing Point-of-care ultrasound-driven diagnostic pathway in people with Dyspnea, run by Aarhus University Hospital at 9 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Point-of-care ultrasound-driven diagnostic pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 9 sitesDenmark
- Study dates
- 25 Jan 2023to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency department contact
- Age ≥ 18 years
- Chief complaint is Dyspnea
- Including physician present
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Aarhus University Hospital
Aarhus, Central Jutland, 8200
University Hospital of Southern Denmark, Esbjerg
Esbjerg, Region Syddanmark, 6700
Gødstrup Regional Hospital
Gødstrup, Central Jutland, 7400
Herlev Hospital
Herlev, Capital Denmark Region, 2730
Horsens Regional Hospital
Horsens, Central Jutland, 8700
Zealand University Hospital, Køge
Køge, Zealand Denmark Region, 4600
Odense University Hospital
Odense, Region Syddanmark, 5000
Slagelse Hospital
Slagelse, Zealand Denmark Region, 4200
Viborg Regional Hospital
Viborg, Central Jutland, 8800
About this study
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
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.
- Conditions
- Dyspnea
- Being tested
- Point-of-care ultrasound-driven diagnostic pathway
- Keywords
- Point-of-care Ultrasound, Emergency Medicine, Diagnostic pathways
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasound-driven diagnostic pathwayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care ultrasound-driven diagnostic pathway | Experimental | 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. Receives: Diagnostic Test: Point-of-care ultrasound-driven diagnostic pathway |
| Standard diagnostic pathway | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
24-hour hospital stay
Proportion of patients with a hospital lenght-of-stay of less than 24 hours.
Measured: From date of hospital admission until the date of first documented hospital discharge, assessed up to 24 hours.
Secondary outcomes (3)
Hospital length-of-stay
Hospital length-of-stay will secondarily be analyzed using time-to-event analysis.
Measured: From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.
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.
Measured: 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
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.
Measured: From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start25 Jan 2023
- Primary completion24 Aug 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stig Holm Ovesen, Aarhus University Hospital
- Investigators
- Stig H Ovesen, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674916
- Sponsor's protocol ID
- pocuspathway
- Acronym
- POCUS PATHWAY
- Status last verified
- Sep 2024
- First submitted
- 16 Dec 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05674916
- Acronym / sponsor ID
- POCUS PATHWAY / pocuspathway
- Conditions
- Dyspnea
- Keywords
- Point-of-care Ultrasound, Emergency Medicine, Diagnostic pathways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-care ultrasound-driven diagnostic pathway | Experimental | Diagnostic Test: Point-of-care ultrasound-driven diagnostic pathwayThe 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. |
| Standard diagnostic pathway | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Emergency department contact
- Age ≥ 18 years
- Chief complaint is Dyspnea
- Including physician present
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasound-driven diagnostic pathwayFocused 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. | Diagnostic test | Point-of-care ultrasound-driven diagnostic pathway |
Primary outcome
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.
3 secondary outcomes
Hospital length-of-stay
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stig H Ovesen principal investigator
Aarhus University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound-driven diagnostic pathway in people with Dyspnea, run by Aarhus University Hospital at 9 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour hospital stay (time frame: From date of hospital admission until the date of first documented hospital discharge, assessed up to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.