A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

NCT ID: NCT02137304

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-04
• Study Completion Date: 2017-09-08

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.

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.

Conditions

Neuromuscular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neuromuscular patients

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic LOFASO, Pr

Role: PRINCIPAL_INVESTIGATOR

AP-HP Hopital R. Poincaré Garches

Locations

Hôpital R. POINCARE

Garches, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31351076 (View on PubMed)

Other Identifiers

2013-A01771-44

Identifier Type: -

Identifier Source: org_study_id