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

NCT05674916 | Completed

• 1 other identifier: pocuspathway
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 9

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.

Conditions

Dyspnea

Keywords

Point-of-care Ultrasound; Emergency Medicine; Diagnostic pathways

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital length-of-stay

  From date of hospital admission until the date of first documented hospital discharge, assessed up to 3 months.

• Image resources

  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

  From date of hospital admission until 72 hours after the date of first documented hospital discharge, assessed up to 3 months.

Study Arms (2)

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.

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.

Interventions

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.

Point-of-care ultrasound-driven diagnostic pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency department contact
• Age ≥ 18 years
• Chief complaint is Dyspnea
• Including physician present

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (9)

Herlev Hospital

Herlev, Capital Denmark Region, 2730, Denmark

Location

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

Gødstrup Regional Hospital

Gødstrup, Central Jutland, 7400, Denmark

Location

Horsens Regional Hospital

Horsens, Central Jutland, 8700, Denmark

Location

Viborg Regional Hospital

Viborg, Central Jutland, 8800, Denmark

Location

University Hospital of Southern Denmark, Esbjerg

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Zealand University Hospital, Køge

Køge, Zealand Denmark Region, 4600, Denmark

Location

Slagelse Hospital

Slagelse, Zealand Denmark Region, 4200, Denmark

Location

Related Links

• Trial website

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stig H Ovesen

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 9, 2023
• Study Start: January 25, 2023
• Primary Completion: August 24, 2024
• Study Completion: September 25, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: There will be no predetermined end date for the data 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.

Locations

DK (9)