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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
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 17, 2014
Last Updated
January 23, 2018
Sponsor
Centre d'Investigation Clinique et Technologique 805
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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

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A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

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