NCT05787665

Brief Summary

Dyspnea is a frequent reason for referral to emergency departments, leading to a 30-day mortality rate of up to 10% and a 3-month rehospitalization rate of over 30%. Multiple etiologies, as well as poor performance of clinical examination and chest radiography, lead to a diagnostic error rate of nearly 30% at the end of emergency department care. These diagnostic errors lead to rehospitalization and an excess mortality rate of more than 50% compared to patients with a correct initial diagnosis, which is explained in particular by the use of inappropriate therapies. Lung ultrasound is a rapid, non-irradiating, non-invasive, inexpensive, reproducible imaging test that can be used at the bedside. It has a better diagnostic performance than chest radiography, commonly performed in emergency departments.The immediate benefit of lung ultrasound for the most common diagnoses in emergency medicine has already been demonstrated. From an organizational point of view, a few studies have shown a benefit of lung ultrasound in reducing the time spent in emergency departments and the number of additional examinations necessary for the final diagnosis. However, there is no data in the literature on the longer term impact of its use in the emergency department. The primary objective is to evaluate the impact of performing lung ultrasound in terms of 3-month mortality and rehospitalization as part of the diagnostic process for patients admitted to the emergency department with dyspnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

March 15, 2023

Last Update Submit

January 6, 2026

Conditions

Keywords

Lung ultrasonographyemergency departmentmortalityrehospitalization

Outcome Measures

Primary Outcomes (2)

  • The primary objective is to evaluate the impact of performing lung ultrasound in terms of 3-month mortality as part of the diagnostic process for patients admitted to the emergency department with dyspnea.

    The primary endpoint is the rate of mortality at 3 months.

    at 3 months

  • The primary objective is to evaluate the impact of performing lung ultrasound in terms of 3-month rehospitalization as part of the diagnostic process for patients admitted to the emergency department with dyspnea.

    the primary endpoint is the rate of rehospitalization at 3 months

    at 3 months

Study Arms (2)

With Lung Ultrasonography

Patient who meet inclusions criteria, and which lung ultrasonography were performed during their medical care in Emergency Department

Other: phone call at 3 months

Without Lung Ultrasonography

Patient who meet inclusions criteria, and which lung ultrasonography were not performed during their medical care in Emergency Department.

Other: phone call at 3 months

Interventions

patients will be called at 3 months to know if they are alive and to know if they have been rehospitalized

With Lung UltrasonographyWithout Lung Ultrasonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will focus on adult patients consulting for dyspnea in the emergency department of the Edouard-Herriot Hospital (HCL).

You may qualify if:

  • Age ≥ 18 years
  • Admission to the emergency department with dyspnea defined by:
  • The functional sign of dyspnea experienced by the patient; Or a clinical sign of respiratory distress.
  • \- Non-opposition of the patient or patient's family if the patient isn't able

You may not qualify if:

  • Trauma-induced dyspnea;
  • Patient being on palliative care;
  • Patient with criteria for initial resuscitation with admission to a critical care unit;
  • Pregnant women, women in labour or nursing mothers;
  • Persons deprived of liberty by judicial or administrative decision;
  • Persons under psychiatric care;
  • Persons admitted to a health or social institution for purposes other than research;
  • Persons of full age subject to a legal protection measure (guardianship, curatorship);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard-Herriot - Emergency Department

Lyon, 69003, France

Location

MeSH Terms

Conditions

DyspneaEmergencies

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • JULIA MORERE, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

June 16, 2023

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations