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Completed

NCT Number: NCT02137304

A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

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.

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Key information

Conditions

Neuromuscular Disease Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital R. POINCARE

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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

  1. optimal pressure treshold based on the best peak flow.

    Time frame: 10 minutes

  2. volume-flow curve aspect

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Acronym: COUGHELP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 13, 2014
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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