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

March 27, 2012
April 11, 2013
June 2011
January 2016   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01569217 on ClinicalTrials.gov Archive Site
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.
Same as current
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Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction
Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion

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".

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Neuromuscular patients

  • Respiratory Failure
  • Neuromuscular Disorder
  • Diaphragmatic Paralysis
Not Provided
  • respiratory muscle dysfunction patients
    Neuromuscular patients
  • diaphragmatic dysfunction
    patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • suspicion of respiratory muscle dysfunction
  • indication of diaphragm exploration

Exclusion Criteria:

  • acute respiratory failure
Both
18 Years and older
No
Contact: Frédéric LOFASO, MD-PhD 0147107941 f.lofaso@rpc.aphp.fr
France
 
NCT01569217
11 003-CCP Ile de France XI, 11.155 bis
Yes
Lofaso, Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
Not Provided
Principal Investigator: Frédéric Lofaso, MD, PhD Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
April 2013

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