Diaphragm Response in Elderly for Acute Monitoring

Not yet recruiting

• Conditions: Acute Dyspnea; Acute Respiratory Failure; Diaphragmatic Ultrasound

• Registration Number: NCT07132268
• Lead Sponsor: Centre Hospitalier de Bethune

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-03
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-11-01
• Primary Completion: 2027-11-08
• Study Completion: 2027-11-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of a severe acute respiratory event within 7 days of admission	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of diaphragmatic excursion AND Etiology of acute dyspnea	within 7 days	To study the association between diaphragmatic excursion curve parameters (EDR, inspiratory time, expiratory time, etc.) and the etiology of acute dyspnea in patients aged 75 years and older admitted for acute dyspnea
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	The discriminatory power of the NEWS2 score in predicting the occurrence of acute respiratory distress, the discriminatory power of the NEWS2 score combined with impaired diaphragmatic function on admission ultrasound.; NEWS 2 : The higher the score, the greater the risk of clinical deterioration. 0-4 : low risk Score of 3 in any individual parameter : low-medium 5-6 : moderate risk; \> or = 7 : high risk

Trial Locations

Locations (9)

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil, France

Centre Hospitalier de Béthune; 🇫🇷 Béthune, France

Centre Hospitalier de Douai; 🇫🇷 Douai, France

Centre Hospitalier Emile Roux; 🇫🇷 Le Puy-en-Velay, France

Centre Hospitalier Sud Ile-de-France; 🇫🇷 Melun, France

Centre Hospitalier de Roubaix; 🇫🇷 Roubaix, France

Centre Hospitalier de Saint-Lô; 🇫🇷 Saint-Lô, France

Centre Hospitalier de Tourcoing; 🇫🇷 Tourcoing, France

Centre Hospitalier de Valenciennes; 🇫🇷 Valenciennes, France