A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases (COUGHELP)

January 23, 2018 updated by: Centre d'Investigation Clinique et Technologique 805
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital R. Poincaré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neuromuscular patients
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)
Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optimal negative pressure treshold value
Time Frame: 20 minutes
Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
optimal pressure treshold based on the best peak flow.
Time Frame: 10 minutes
10 minutes
volume-flow curve aspect
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Frederic LOFASO, Pr, AP-HP Hopital R. Poincaré Garches

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2014

Primary Completion (Actual)

September 8, 2017

Study Completion (Actual)

September 8, 2017

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A01771-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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