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
  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: 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) ] [ 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


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • Age [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Sexe [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, Bobbia EDDRA Repro
Study First Received: December 4, 2012
Last Updated: March 3, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on September 14, 2014