Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847299
Acronym
TWOTECH
Enrollment
20
Registered
2016-07-28
Start date
2016-09-30
Completion date
2017-03-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Disease

Keywords

cough help, mechanical insufflation, mechanical ventilation, neuromuscular diseases, peak cough flow

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)

Interventions

DEVICEincrease of cough peak flow (Astral ventilator)

instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method

Sponsors

ResMed
CollaboratorINDUSTRY
Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Peak cough flow1 year

Secondary

MeasureTime frame
effective cough time1 year
inspired volume1 year
maximal expired volume1 year
respiratory comfort (Visual Analog Scale)1 year
subjective patient's effectiveness of cough (Visual Analog Scale)1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026