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

Not Applicable

Completed

• Conditions: Neuromuscular Disease
• Interventions: Device: increase of cough peak flow ("Astral ventilator")

• Registration Number: NCT02847299
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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)

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Study Start: 2016-09
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Astral ventilator	increase of cough peak flow ("Astral ventilator")	instrumental increase of cough peak flow with air stacking
Astral ventilator - mode kiné	increase of cough peak flow ("Astral ventilator")	instrumental increase of cough peak flow with hyperinsufflation

Primary Outcome Measures

Name	Time	Method
Peak cough flow	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AP-HP Hopital R. Poincaré; 🇫🇷 Garches, Ile de France, France