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Clinical Trials/NCT02847299
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

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)

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

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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