Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation (TWOTECH)

Centre d'Investigation Clinique et Technologique 805

Status: Completed

Conditions: Neuromuscular Disease

Treatments: Device: increase of cough peak flow ("Astral ventilator")

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02847299

2015-A00171-48

Details and patient eligibility

About

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

Full description

Primary outcome : Peak Expiratory Flow (PEF)

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Astral ventilator

Experimental group

Description:

instrumental increase of cough peak flow with air stacking

Treatment:

Device: increase of cough peak flow ("Astral ventilator")

Astral ventilator - mode kiné

Experimental group

Description:

instrumental increase of cough peak flow with hyperinsufflation

Treatment:

Device: increase of cough peak flow ("Astral ventilator")