Clinical trial NCT02847299: Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Official title: Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Disease
Keywords: cough help
mechanical insufflation
mechanical ventilation
neuromuscular diseases
peak cough flow
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2016-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Peak cough flow
timeFrame: 1 year
Secondary outcomes:
measure: effective cough time
timeFrame: 1 year
measure: inspired volume
timeFrame: 1 year
measure: maximal expired volume
timeFrame: 1 year
measure: respiratory comfort (Visual Analog Scale)
timeFrame: 1 year
measure: subjective patient's effectiveness of cough (Visual Analog Scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: Garches
country: France
facility: AP-HP Hopital R. Poincaré
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederic LOFASO, Pr
role: PRINCIPAL_INVESTIGATOR
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