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Completed

NCT Number: NCT01743105

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diaphragm excursion measures 1

Procedure

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.

Diaphragm excursion measures 2

Procedure

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.

Primary outcomes

  1. Diaphragmatic excursion, first measure by investigator 1

    Time frame: Baseline (day 0)

    in centimeters

  2. Diaphragmatic excursion, first measure by investigator 2

    Time frame: Baseline (day 0)

    in centimeters

Secondary outcomes

  1. Time necessary to measure diaphragm movement amplitude (minutes)

    Time frame: Baseline (day 0)

  2. Feasibility (yes/no)

    Time frame: Baseline (day 0)

    We were able to perform the required measurements (yes/no)

  3. Diaphragmatic excursion, second measure by investigator 1

    Time frame: Baseline (day 0)

    (centimeters)

  4. Diaphragmatic excursion, second measure by investigator 2

    Time frame: Baseline (day 0)

    (centimeters)

Other outcomes

  1. Age

    Time frame: Baseline (day 0)

  2. Sexe

    Time frame: Baseline (day 0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: EDDRA-Repro

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2012
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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