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Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

This study is currently recruiting participants.
Verified April 2013 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
Lofaso, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01569217
First received: March 27, 2012
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Respiratory Failure
Neuromuscular Disorder
Diaphragmatic Paralysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • compartmental distribution of the inspired/expired volumes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

    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:
  • left side and right side contribution to the inspired/expired volumes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: June 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
respiratory muscle dysfunction patients
Neuromuscular patients
diaphragmatic dysfunction
patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neuromuscular patients

Criteria

Inclusion Criteria:

  • suspicion of respiratory muscle dysfunction
  • indication of diaphragm exploration

Exclusion Criteria:

  • acute respiratory failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569217

Contacts
Contact: Frédéric LOFASO, MD-PhD 0147107941 f.lofaso@rpc.aphp.fr

Locations
France
Raymond Poincaré Hospital Recruiting
Garches, France, 92380
Contact: Frédéric Lofaso, MD PhD     33 1 47 10 79 41     f.lofaso@rpc.aphp.fr    
Principal Investigator: Frédéric Lofaso, Professor            
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Frédéric Lofaso, MD, PhD Centre d'Investigation Clinique et Technologique 805
  More Information

No publications provided

Responsible Party: Lofaso, MD PhD, Professor, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01569217     History of Changes
Other Study ID Numbers: 11 003-CCP Ile de France XI, 11.155 bis
Study First Received: March 27, 2012
Last Updated: April 11, 2013
Health Authority: France: Institutional Ethical Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Diaphragm
Abdomen
Breathing pattern
dyspnea

Additional relevant MeSH terms:
Neuromuscular Diseases
Respiratory Paralysis
Paralysis
Respiratory Insufficiency
Nervous System Diseases
 Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013