Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

Respiratory Failure Clinical Trial

— DREM  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01569217
• Other study ID #: 11 003-CCP Ile de France XI
• Secondary ID: 11.155 bis
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 27, 2012
• Last updated: April 28, 2017
• Start date: June 2011
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• suspicion of respiratory muscle dysfunction

• indication of diaphragm exploration

Exclusion Criteria:

• acute respiratory failure

Related Conditions & MeSH terms

• Diaphragmatic Paralysis
• Neuromuscular Diseases
• Neuromuscular Disorder
• Paralysis
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Paralysis

Locations

Country	Name	City	State
France	Raymond Poincaré Hospital	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compartmental distribution of the inspired/expired volumes	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.	1 hour
Secondary	left side and right side contribution to the inspired/expired volumes	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.	1 hour