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Clinical Trials/NCT02137304
NCT02137304CompletedNot Applicable

A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Centre d'Investigation Clinique et Technologique 8052 sites in 1 country40 target enrollmentStarted: February 4, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
optimal negative pressure treshold value

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

neuromuscular patients

Experimental

Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

Intervention: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) (Device)

Outcomes

Primary Outcomes

optimal negative pressure treshold value

Time Frame: 20 minutes

Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute

Secondary Outcomes

  • optimal pressure treshold based on the best peak flow.(10 minutes)
  • volume-flow curve aspect(5 minutes)

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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