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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01743105
First received: December 4, 2012
Last updated: March 3, 2014
Last verified: March 2014

December 4, 2012
March 3, 2014
August 2013
January 2014   (final data collection date for primary outcome measure)
  • Diaphragmatic excursion, first measure by investigator 1 [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    in centimeters
  • Diaphragmatic excursion, first measure by investigator 2 [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    in centimeters
Same as current
Complete list of historical versions of study NCT01743105 on ClinicalTrials.gov Archive Site
  • Time necessary to measure diaphragm movement amplitude (minutes) [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Feasibility (yes/no) [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    We were able to perform the required measurements (yes/no)
  • Diaphragmatic excursion, second measure by investigator 1 [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    (centimeters)
  • Diaphragmatic excursion, second measure by investigator 2 [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
    (centimeters)
Same as current
  • Age [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Sexe [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
Same as current
 
Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER
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.

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).
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Respiratory Distress Syndrome, Adult
  • 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.
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

Interventions:
  • Procedure: Diaphragm excursion measures 1
  • Procedure: Diaphragm excursion measures 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01743105
LOCAL/2012/XBAC-01, 2012-A01094-39, Bobbia EDDRA Repro
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP