DREM: Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

Sponsor
Centre d'Investigation Clinique et Technologique 805 (Other)
Overall Status
Unknown status
CT.gov ID
NCT01569217
Collaborator
(none)
200
1
85
2.4

Study Details

Study Description

Brief Summary

The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. The final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patients which had suspected respiratory muscle dysfunction will have usual exploration of the respiratory muscles according to the clinician prescription. These explorations can include :

    • Lung volumes in seating and supine position

    • Maximal inspiratory and expiratory pressures

    • Maximal sniff pressures

    And when diaphragmatic dysfunction is suspected :
    • Maximal transdiaphragmatic pressure

    • Phrenic nerve conduction

    These patients will also beneficiate to the determination of volume variations of the upper rib cage, the lower rib cage and the abdominal compartments by using Opto-electronic plethysmography.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion
    Study Start Date :
    Jun 1, 2011
    Anticipated Primary Completion Date :
    Jun 1, 2018
    Anticipated Study Completion Date :
    Jul 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    respiratory muscle dysfunction patients

    Neuromuscular patients

    diaphragmatic dysfunction

    patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement

    Outcome Measures

    Primary Outcome Measures

    1. compartmental distribution of the inspired/expired volumes [1 hour]

      Measurements of the thoraco-abdominal motion and of the global lung volume changes. Measurements will be done during spontaneous breathing and during vital capacity maneuvers. Therefore the tidal volume, the inspiratory capacity and the expiratory reserve volume will be measured in liters and for each compartiment (upper thorax, lower thorax, abdomen) contribution of these volumes will be expressed in percentage.

    Secondary Outcome Measures

    1. left side and right side contribution to the inspired/expired volumes [1 hour]

      Measurements will be done during spontaneous breathing and during vital capacity maneuvers. Therefore the tidal volume, the inspiratory capacity and the expiratory reserve volume will be measured in liters and each side contribution of these volumes will be expressed in percentage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • suspicion of respiratory muscle dysfunction

    • indication of diaphragm exploration

    Exclusion Criteria:
    • acute respiratory failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Raymond Poincaré Hospital Garches France 92380

    Sponsors and Collaborators

    • Centre d'Investigation Clinique et Technologique 805

    Investigators

    • Principal Investigator: Frédéric Lofaso, MD, PhD, Centre d'Investigation Clinique et Technologique 805

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lofaso, MD PhD, Professor, Centre d'Investigation Clinique et Technologique 805
    ClinicalTrials.gov Identifier:
    NCT01569217
    Other Study ID Numbers:
    • 11 003-CCP Ile de France XI
    • 11.155 bis
    First Posted:
    Apr 3, 2012
    Last Update Posted:
    May 1, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Lofaso, MD PhD, Professor, Centre d'Investigation Clinique et Technologique 805
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2017