A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Not Applicable

Completed

• Conditions: Neuromuscular Disease
• Interventions: Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

• Registration Number: NCT02137304
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Detailed Description

he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Study Timeline

• Study Start: 2014-02-04
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Primary Completion: 2017-09-08
• Study Completion: 2017-09-08
• Status Verified: 2017-11
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• man or female age18 years
• neuromuscular disease
• coughassist adaptation treatment
• peak cough flow<270liter/minute

Exclusion Criteria

• acute organ failure
• insufflation contrindication
• pregnant women/no affiliation to a social security scheme
• plan of legal protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neuromuscular patients	Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)	Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

Primary Outcome Measures

Name	Time	Method
optimal negative pressure treshold value	20 minutes	Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute

Secondary Outcome Measures

Name	Time	Method
volume-flow curve aspect	5 minutes
optimal pressure treshold based on the best peak flow.	10 minutes

Trial Locations

Locations (1)

Hôpital R. POINCARE; 🇫🇷 Garches, France