Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations. (coughassistAFM)

March 23, 2015 updated by: Centre d'Investigation Clinique et Technologique 805
A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches, France).

Respiratory parameters and comfort will be evaluated before and after (5min,

1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern will be recorded allowing the measurements of respiratory frequency, tidal volume, Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of tension-time index (TT0.1).

Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse oxymetry.

Respiratory comfort will be assessed with a visual analog scale. Optoelectronic plethysmography will be use to perform regional ventilation evaluation. Using chest wall motion analysis we will compute respiratory participation of upper, lower thorax and abdomen, right and left side.

Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms of action of MI-E on respiration and chest-wall motion will be analysed and the persistence of the beneficial effect of MI-E will be assessed.

Study Type

Interventional

Enrollment (Actual)

16

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 Raymond 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged more than 18 years
  • Written consents
  • Neuromuscular disorders
  • Hemodynamic stability

Exclusion Criteria:

  • Pulmonary disorder
  • Acute respiratory failure
  • Cognitive deficit

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cough assist session
Mechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O.
Device: Plethysmography opto electronic
Procedure: respiratory parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal inspiratory pressures
Time Frame: 2 hours
measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.
2 hours

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

University of Versailles

Investigators

  • Principal Investigator: Frederic LOFASO, MD PHD, Raymond Poincaré Hospital
  • Principal Investigator: Michel Petitjean, MDPHD, Raymond Poincaré Hospital

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

November 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-A01042-37

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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