NCT02847299
Completed
Not Applicable
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Centre d'Investigation Clinique et Technologique 8051 site in 1 country20 target enrollmentSeptember 2016
ConditionsNeuromuscular Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromuscular Disease
- Sponsor
- Centre d'Investigation Clinique et Technologique 805
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Peak cough flow
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance techniques requiring no equipment other than the volumetric fan. The two methods are air-stacking and hyperinflation .
The study is a Cross-over, monocentric and open label study
Detailed Description
Primary outcome : Peak Expiratory Flow (PEF)
Investigators
Eligibility Criteria
Inclusion Criteria
- •age\>18 years, neuromuscular disease,
- •restrictive syndrome and/or cough peak flow \< 270.l/mn and/or maximal expiratory pressure \< 40 cm HO2,
- •patient under non invasive ventilation
- •steady state for at least one month
- •written consent form given
Exclusion Criteria
- •bronchial congestion
- •hemodynamic instability
- •previous pneumothorax or emphysema bubbles
- •Major bulbar dysfunction
- •plan of legal protection
- •pregnant or breastfeeding women
- •no affiliation to a social security scheme
Outcomes
Primary Outcomes
Peak cough flow
Time Frame: 1 year
Secondary Outcomes
- maximal expired volume(1 year)
- respiratory comfort (Visual Analog Scale)(1 year)
- inspired volume(1 year)
- effective cough time(1 year)
- subjective patient's effectiveness of cough (Visual Analog Scale)(1 year)
Study Sites (1)
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