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

Primary Purpose

Dyspnea

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Point-of-care ultrasound-driven diagnostic pathway
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspnea focused on measuring Point-of-care Ultrasound, Emergency Medicine, Diagnostic pathways

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Emergency department contact Age ≥ 18 years Chief complaint is Dyspnea Including physician present Exclusion Criteria: 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

Sites / Locations

  • Herlev HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Gødstrup Regional HospitalRecruiting
  • Horsens Regional HospitalRecruiting
  • Viborg Regional HospitalRecruiting
  • University Hospital of Southern Denmark, EsbjergRecruiting
  • Odense University HospitalRecruiting
  • Zealand University Hospital, KøgeRecruiting
  • Slagelse HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Point-of-care ultrasound-driven diagnostic pathway

Standard diagnostic pathway

Arm Description

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 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.

Outcomes

Primary Outcome Measures

24-hour hospital stay
Proportion of patients with a hospital lenght-of-stay of less than 24 hours.

Secondary Outcome Measures

Hospital length-of-stay
Hospital length-of-stay will secondarily be analyzed using time-to-event analysis.
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.
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.

Full Information

First Posted
December 16, 2022
Last Updated
May 3, 2023
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05674916
Brief Title
Point-Of-Care Ultrasound-Driven vs Standard Diagnostic Pathway in Emergency Department Patients With Dyspnea
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
February 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Point-of-care Ultrasound, Emergency Medicine, Diagnostic pathways

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
642 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Point-of-care ultrasound-driven diagnostic pathway
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard diagnostic pathway
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-care ultrasound-driven diagnostic pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
24-hour hospital stay
Description
Proportion of patients with a hospital lenght-of-stay of less than 24 hours.
Time Frame
From date of hospital admission until the date of first documented hospital discharge, assessed up to 24 hours.
Secondary Outcome Measure Information:
Title
Hospital length-of-stay
Description
Hospital length-of-stay will secondarily be analyzed using time-to-event analysis.
Time Frame
From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.
Title
Image resources
Description
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.
Time Frame
From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.
Title
Number of participants with the composite outcome of 72-hour revisits and overall mortality
Description
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.
Time Frame
From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Emergency department contact Age ≥ 18 years Chief complaint is Dyspnea Including physician present Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stig H Ovesen
Phone
+4527121505
Email
stigholm@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Weile
Email
jesper.weile@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stig H Ovesen
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
State/Province
Capital Denmark Region
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Wamberg, MD
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaj Raaber, MD, PhD.
Facility Name
Gødstrup Regional Hospital
City
Gødstrup
State/Province
Central Denmark Region
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Møllekær, MD, PhD
Facility Name
Horsens Regional Hospital
City
Horsens
State/Province
Central Denmark Region
ZIP/Postal Code
8700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stig Ovesen, MD
Facility Name
Viborg Regional Hospital
City
Viborg
State/Province
Central Denmark Region
ZIP/Postal Code
8800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Nielsen, MD
Facility Name
University Hospital of Southern Denmark, Esbjerg
City
Esbjerg
State/Province
South Denmark Region
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Biesenbach, MD, PhD
Facility Name
Odense University Hospital
City
Odense
State/Province
South Denmark Region
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Posth, MD, PhD
Facility Name
Zealand University Hospital, Køge
City
Køge
State/Province
Zealand Denmark Region
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Møgelvang, MD
Facility Name
Slagelse Hospital
City
Slagelse
State/Province
Zealand Denmark Region
ZIP/Postal Code
4200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Dan Arvig, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://pocuspathway.org/
Description
Trial website

Learn more about this trial

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

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