Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER (EDDRA-Repro)

Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room

The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Procedure: Diaphragm excursion measures 1; Procedure: Diaphragm excursion measures 2

Detailed Description

The secondary objectives of this study are:

• To assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients).
• To evaluate the time required for the measurement.
• To assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient has acute respiratory distress defined by a respiratory rate > 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) <90% and / or pH <7.35 and carbon dioxide partial pressure (pCO2) > 6 kPa (45 mm Hg)
• The patient breathes spontaneously (no respirator)

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient or his/her representative refuses to sign the consent
• It is impossible to correctly inform the patient, or to correctly inform his/her representative
• The patient is pregnant, parturient, or breastfeeding
• The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...).
• Patient admitted with respiratory support treatment in progress
• Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements

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: 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. Interventions: Diaphragm excursion measures 1, Diaphragm excursion measures 2

Procedure: Diaphragm excursion measures 1; A first diaphragm ultrasound study will be carried out by investigator 1. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.; Procedure: Diaphragm excursion measures 2; A second diaphragm ultrasound study will be carried out immediately after Ultrasound 1, and by investigator 2. The results are blinded between investigators. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic excursion, first measure by investigator 1	in centimeters	Baseline (day 0)
Diaphragmatic excursion, first measure by investigator 2	in centimeters	Baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time necessary to measure diaphragm movement amplitude (minutes)		Baseline (day 0)
Feasibility (yes/no)	We were able to perform the required measurements (yes/no)	Baseline (day 0)
Diaphragmatic excursion, second measure by investigator 1	(centimeters)	Baseline (day 0)
Diaphragmatic excursion, second measure by investigator 2	(centimeters)	Baseline (day 0)

Other Outcome Measures

Outcome Measure	Time Frame
Age	Baseline (day 0)
Sexe	Baseline (day 0)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Bobbia X, Clement A, Claret PG, Bastide S, Alonso S, Wagner P, Tison T, Muller L, de La Coussaye JE. Diaphragmatic excursion measurement in emergency patients with acute dyspnea: toward a new diagnostic tool? Am J Emerg Med. 2016 Aug;34(8):1653-7. doi: 10.1016/j.ajem.2016.05.055. Epub 2016 May 24.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 27, 2014
• Study Completion (Actual): January 27, 2014

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimated): December 6, 2012

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

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/2012/XBAC-01; 2012-A01094-39 (Other Identifier: RCB number); Bobbia EDDRA Repro (Other Identifier: BESPIM, Nîmes University Hospital)