NCT07132268

Brief Summary

Acute dyspnea is a common cause of emergency department admissions among elderly patients. Acute respiratory failure is often multifactorial and requires rapid and reliable evaluation. Currently, management relies on clinical, biological, and radiological assessments, but diaphragmatic ultrasound could provide an additional tool for real-time respiratory function evaluation. This study aims to integrate this non-invasive technology into the initial assessment of patients to improve care pathways. Hypothesis : Diaphragmatic ultrasound enables reliable assessment of respiratory function and can predict the need for mechanical ventilation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
24mo left

Started Jun 2026

Geographic Reach
1 country

9 active sites

Status
not yet recruiting

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

July 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

July 3, 2025

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a severe acute respiratory event within 7 days of admission

    * Placement on invasive mechanical ventilation (intubation) or non invasive ventilation (NIV, high-flow oxygen therapy), * Respiratory death, confirmed by an independent adjudication committee blinded to the ultrasound results. Explanatory variable: The presence of impaired diaphragmatic function at admission will be defined by: * a Tdi (tele-inspiratory thickness) \<10%, and/or * a diaphragmatic excursion \<10 mm.

    WITHIN 7 DAYS OF ADMISSION

Secondary Outcomes (2)

  • Measurement of diaphragmatic excursion AND Etiology of acute dyspnea

    within 7 days

  • To evaluate the contribution of diaphragmatic ultrasound to the NEWS2 score performed on admission in predicting the occurrence of acute respiratory distress within 7 days.

    within 7 days

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients Aged 75 and Over Admitted to the Emergency Department for Acute Dyspnea

You may qualify if:

  • Patients aged ≥ 75 years
  • Emergency admission for acute dyspnea
  • Requiring an emergency ultrsoung.

You may not qualify if:

  • Acute respiratory distress requiring immediate invasive or non-invasive ventilation
  • Respiratory rate ≥ 25 breaths/min, and/or SpO2 ≤ 90% on room air, and/or PaO2 ≤ 60 mmHg
  • Known diaphragmatic paralysis
  • Patients with degenerative neuromuscular disease
  • State of shock: systolic blood pressure \< 90 mmHg and/or mean arterial pressure \< 65 mmHg and/or presence of skin mottling and/or CTR \> 3s
  • Lactate levels \> 2 mmol/L
  • Hypercapnic respiratory acidosis (pH \< 7.38 and PaCO2 \> 45 mmHg)
  • Dyspnea due to metabolic acidosis (e.g., diabetic ketoacidosis, renal failure)
  • Dyspnea of traumatic origin
  • Refusal to participate or inability to provide informed consent
  • Patients deprived of liberty
  • Patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

Centre Hospitalier de Béthune

Béthune, 62408, France

Location

Centre Hospitalier de Douai

Douai, 59507, France

Location

Centre Hospitalier Emile Roux

Le Puy-en-Velay, 43000, France

Location

Centre Hospitalier Sud Ile-de-France

Melun, 77000, France

Location

Centre Hospitalier de Roubaix

Roubaix, 59100, France

Location

Centre Hospitalier de Saint-Lô

Saint-Lô, 50000, France

Location

Centre Hospitalier de Tourcoing

Tourcoing, 59208, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

Study Officials

  • Alain-Eric DUBART

    Centre Hospitalier de Béthune-Beuvry

    STUDY DIRECTOR

Central Study Contacts

Tristan CARRIE, Doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 3, 2025

First Posted

August 20, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Locations