A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases (COUGHELP)
Primary Purpose
Neuromuscular Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Disease focused on measuring cough help, in-exsufflation, neuromuscular disease, cough assistance optimization, efficient cough flow
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
Sites / Locations
- Hôpital R. POINCARE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
neuromuscular patients
Arm Description
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
optimal pressure treshold based on the best peak flow.
volume-flow curve aspect
Full Information
NCT ID
NCT02137304
First Posted
April 17, 2014
Last Updated
January 23, 2018
Sponsor
Centre d'Investigation Clinique et Technologique 805
1. Study Identification
Unique Protocol Identification Number
NCT02137304
Brief Title
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
Acronym
COUGHELP
Official Title
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 4, 2014 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Disease
Keywords
cough help, in-exsufflation, neuromuscular disease, cough assistance optimization, efficient cough flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neuromuscular patients
Arm Type
Experimental
Arm Description
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Intervention Type
Device
Intervention Name(s)
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Intervention Description
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow
Primary Outcome Measure Information:
Title
optimal negative pressure treshold value
Description
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 Outcome Measure Information:
Title
optimal pressure treshold based on the best peak flow.
Time Frame
10 minutes
Title
volume-flow curve aspect
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic LOFASO, Pr
Organizational Affiliation
AP-HP Hopital R. Poincaré Garches
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital R. POINCARE
City
Garches
ZIP/Postal Code
92380
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31351076
Citation
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.
Results Reference
derived
Learn more about this trial
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
We'll reach out to this number within 24 hrs