Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

• Conditions: Respiratory Failure; Diaphragmatic Paralysis; Neuromuscular Disorder

• Registration Number: NCT01569217
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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".

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01
• Primary Completion: 2018-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• suspicion of respiratory muscle dysfunction
• indication of diaphragm exploration

Exclusion Criteria

• acute respiratory failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Raymond Poincaré Hospital; 🇫🇷 Garches, France