Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department (EDDRAPro)

Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis

The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Device: Vivid S6 GE Ultrasound

Detailed Description

The secondary objectives of this study are:

A-determine a prognostic threshold for diaphragmatic excursion measures able to predict the use of mechanical ventilation (invasive or not) in the first four hours.

B-to study the association between CDA values and persistence of respiratory distress during the first 4 hours of care among patients who, at 4 hours, are not mechanically ventilated.

C-to study the association between CDA values and respiratory re-exacerbation or a continuing need for mechanical ventilation during the 24 first hours after admission to the emergency room D-to study the association between diaphragmatic excursion measures made after initial emergency care (at 4 hours; =CDH4), and the persistence of respiratory distress at 4 hours, in patients who at 4 hours are not mechanically ventilated.

E-to study the association between CDH4 values and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated F-to study the association between changes in values of diaphragmatic excursion measure before and after initial emergency care (CDA → CDH4) and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated.

G-analyze patient outcomes by subgroup according to diagnosis (decompensated COPD, OAP, lung disease, asthma, pleural disease).

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Perpignan, France, 66046
    • CH de Perpignan - Hôpital Saint Jean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
• Patient affiliated with or beneficiary of a health insurance plan
• Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)]
• Breathing spontaneously (no ventilation)

Exclusion Criteria:

• Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
• Patient under judicial protection or any kind of guardianship
• Refusal to sign the consent
• Patient pregnant, parturient, or lactating
• Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
• Patient who received mechanical ventilation at home
• Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
• Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
• Patient suffering from a pneumothorax

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prognostic study population; The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria. Intervention: Diaphragmatic ultrasound	Device: Vivid S6 GE Ultrasound; Diaphragmatic ultrasound will be performed by the physician supporting the patient on arrival and also at 4 hours later in the beginning of therapeutic management. The patient will be monitored for 24 hours following inclusion. The exams will all be done with the same ultrasound system (Vivid S6 GE Ultrasound) and a phased array probe, also called a cardiac probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of diaphragmatic excursion by M-mode ultrasound	in centimeters	Day 0, baseline
Use of ventilation within the first 4 hours	yes/no	Day 0, baseline + 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of diaphragmatic excursion by M-mode ultrasound	in centimeters	Day 0, baseline + 4 hours
Acute respiratory distress signs within the first 4 hours	yes/no	Day 0, baseline + 4 hours
Signs of respiratory re aggravation at 24 hours	yes/no	Day 1
Diagnosis	qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Xavier Bobbia, MD, Centre Hospitalier Universitaire De Nimes

Publications and helpful links

General Publications

• Clement A, Zieleskiewicz L, Bonnec JM, Occean BV, Bastide S, Muller L, de La Coussaye JE, Boussuges A, Claret PG, Bobbia X. Diaphragmatic excursion measurement in emergency department patients with acute dyspnea to predict mechanical ventilation use. Am J Emerg Med. 2020 Oct;38(10):2081-2087. doi: 10.1016/j.ajem.2020.06.044. Epub 2020 Jun 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2014
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimated): October 24, 2014

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: ultrasound; emergency room; diaphragm movement
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Distress Syndrome; Emergencies
• Other Study ID Numbers: LOCAL/20143/XBAC-01; 2014-A00511-46 (Other Identifier: ANSM)