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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Image resources |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stig H Ovesen | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Herlev | Capital Denmark Region | 2730 | Denmark | ||
| Aarhus University Hospital |
Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.
There will be no predetermined end date for the data sharing.
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.
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|
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 | 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. |
| Aarhus |
| Central Jutland |
| 8200 |
| Denmark |
| Gødstrup Regional Hospital | Gødstrup | Central Jutland | 7400 | Denmark |
| Horsens Regional Hospital | Horsens | Central Jutland | 8700 | Denmark |
| Viborg Regional Hospital | Viborg | Central Jutland | 8800 | Denmark |
| University Hospital of Southern Denmark, Esbjerg | Esbjerg | Region Syddanmark | 6700 | Denmark |
| Odense University Hospital | Odense | Region Syddanmark | 5000 | Denmark |
| Zealand University Hospital, Køge | Køge | Zealand Denmark Region | 4600 | Denmark |
| Slagelse Hospital | Slagelse | Zealand Denmark Region | 4200 | Denmark |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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