NCT01743105

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2014

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

December 4, 2012

Last Update Submit

November 14, 2025

Conditions

Respiratory Distress Syndrome, Adult

Keywords

diaphragm movementultrasoundemergency room

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Time necessary to measure diaphragm movement amplitude (minutes)

    Baseline (day 0)

  • Feasibility (yes/no)

    Baseline (day 0)

  • Diaphragmatic excursion, second measure by investigator 1

    Baseline (day 0)

  • Diaphragmatic excursion, second measure by investigator 2

    Baseline (day 0)

Other Outcomes (2)

  • Age

    Baseline (day 0)

  • Sexe

    Baseline (day 0)

Study Arms (1)

Study population

EXPERIMENTAL

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 1Procedure: Diaphragm excursion measures 2

Interventions

Diaphragm excursion measures 1PROCEDURE

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.

Study population
Diaphragm excursion measures 2PROCEDURE

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.

Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 27251231RESULT

MeSH Terms

Conditions

Respiratory Distress SyndromeEmergencies

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xavier Bobbia, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2012

First Posted

December 6, 2012

Study Start

August 1, 2013

Primary Completion

January 27, 2014

Study Completion

January 27, 2014

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

FR(1)