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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743105
First Posted: December 6, 2012
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition Intervention
Respiratory Distress Syndrome, Adult Procedure: Diaphragm excursion measures 1 Procedure: Diaphragm excursion measures 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Diaphragmatic excursion, first measure by investigator 1 [ Time Frame: Baseline (day 0) ]
    in centimeters

  • Diaphragmatic excursion, first measure by investigator 2 [ Time Frame: Baseline (day 0) ]
    in centimeters


Secondary Outcome Measures:
  • Time necessary to measure diaphragm movement amplitude (minutes) [ Time Frame: Baseline (day 0) ]
  • Feasibility (yes/no) [ Time Frame: Baseline (day 0) ]
    We were able to perform the required measurements (yes/no)

  • Diaphragmatic excursion, second measure by investigator 1 [ Time Frame: Baseline (day 0) ]
    (centimeters)

  • Diaphragmatic excursion, second measure by investigator 2 [ Time Frame: Baseline (day 0) ]
    (centimeters)


Other Outcome Measures:
  • Age [ Time Frame: Baseline (day 0) ]
  • Sexe [ Time Frame: Baseline (day 0) ]

Enrollment: 26
Study Start Date: August 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743105


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01743105     History of Changes
Other Study ID Numbers: LOCAL/2012/XBAC-01
2012-A01094-39 ( Other Identifier: RCB number )
Bobbia EDDRA Repro ( Other Identifier: BESPIM, Nîmes University Hospital )
First Submitted: December 4, 2012
First Posted: December 6, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
diaphragm movement
ultrasound
emergency room

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury


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