A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Neuromuscular Disease Clinical Trial

— COUGHELP  

Official title:

A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137304
• Other study ID #: 2013-A01771-44
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: January 23, 2018
• Start date: February 4, 2014
• Est. completion date: September 8, 2017

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 8, 2017
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

Device:
• Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow

Locations

Country	Name	City	State
France	Hôpital R. POINCARE	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	optimal negative pressure treshold value	Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute	20 minutes
Secondary	optimal pressure treshold based on the best peak flow.		10 minutes
Secondary	volume-flow curve aspect		5 minutes