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CompletedNCT02137304COUGHELPUpdated Jan 25, 2018

A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

An interventional study of Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) in Neuromuscular Disease, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Read the detailed description

he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

02

Conditions studied

  • Neuromuscular Disease

Keywords

  • cough help
  • in-exsufflation
  • neuromuscular disease
  • cough assistance optimization
  • efficient cough flow
03

In context

Neuromuscular Diseases

300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.

This study's enrollment of 40 is above the median of 32 across 168 interventional studies indexed under Neuromuscular Diseases.

Browse Neuromuscular Diseases studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • man or female age18 years
  • neuromuscular disease
  • coughassist adaptation treatment
  • peak cough flow\<270liter/minute

Exclusion criteria

Exclusion Criteria:

  • acute organ failure
  • insufflation contrindication
  • pregnant women/no affiliation to a social security scheme
  • plan of legal protection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    neuromuscular patients

    Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

    Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

Interventions

  • DeviceCough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

    Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow

06

What researchers measure

Primary outcomes

  1. optimal negative pressure treshold value

    Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute

    Time frame: 20 minutes

Secondary outcomes

  1. optimal pressure treshold based on the best peak flow.

    Time frame: 10 minutes

  2. volume-flow curve aspect

    Time frame: 5 minutes

07

Study locations

1 site
  • Hôpital R. POINCARE
    Garches, 92380, France
08

References and documents

Publications

  • Lacombe M, Bore A, Amo Castrillo LD, Boussaid G, Falaize L, Vlachos E, Orlikowski D, Prigent H, Lofaso F. Peak Cough Flow Fails to Detect Upper Airway Collapse During Negative Pressure Titration for Cough-Assist. Arch Phys Med Rehabil. 2019 Dec;100(12):2346-2353. doi: 10.1016/j.apmr.2019.06.012. Epub 2019 Jul 24. PubMed 31351076 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02137304
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Sponsor
First posted
May 13, 2014
Start date
Feb 4, 2014
Primary completion
Sep 8, 2017
Completion
Sep 8, 2017
Last update
Jan 25, 2018

Study contacts

Frederic LOFASO, Pr
principal investigator · AP-HP Hopital R. Poincaré Garches

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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