NCT02137304

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2017

Completed
Last Updated

January 25, 2018

Status Verified

November 1, 2017

Enrollment Period

3.6 years

First QC Date

April 17, 2014

Last Update Submit

January 23, 2018

Conditions

Neuromuscular Disease

Keywords

cough helpin-exsufflationneuromuscular diseasecough assistance optimizationefficient cough flow

Outcome Measures

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

    20 minutes

Secondary Outcomes (2)

  • optimal pressure treshold based on the best peak flow.

    10 minutes

  • volume-flow curve aspect

    5 minutes

Study Arms (1)

neuromuscular patients

EXPERIMENTAL

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

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

Interventions

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

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

neuromuscular patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital R. POINCARE

Garches, 92380, France

Location

Related Publications (1)

  • 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.

    PMID: 31351076DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Frederic LOFASO, Pr

    AP-HP Hopital R. Poincaré Garches

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

May 13, 2014

Study Start

February 4, 2014

Primary Completion

September 8, 2017

Study Completion

September 8, 2017

Last Updated

January 25, 2018

Record last verified: 2017-11

Locations

FR(1)