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

Sponsor
Centre d'Investigation Clinique et Technologique 805 (Other)
Overall Status
Completed
CT.gov ID
NCT02236104
Collaborator
University of Versailles (Other)
16
Enrollment
1
Location
1
Arm
38
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Plethysmography opto electronic
  • Procedure: respiratory parameters
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. maximal inspiratory pressures [2 hours]

    measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adults aged more than 18 years

  • Written consents

  • Neuromuscular disorders

  • Hemodynamic stability

Exclusion Criteria:

  • Pulmonary disorder

  • Acute respiratory failure

  • Cognitive deficit

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Raymond Poincaré Garches France 92380

Sponsors and Collaborators

  • Centre d'Investigation Clinique et Technologique 805
  • University of Versailles

Investigators

  • Principal Investigator: Frederic LOFASO, MD PHD, Raymond poincare hospital
  • Principal Investigator: Michel Petitjean, MDPHD, Raymond Poincare hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT02236104
Other Study ID Numbers:
  • 2010-A01042-37
First Posted:
Sep 10, 2014
Last Update Posted:
Mar 24, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Centre d'Investigation Clinique et Technologique 805
neuromuscular disorders
mechanical insufflation-exsufflation
respiratory parameters
plethysmography opto electronic
Vital capacity

Study Results

No Results Posted as of Mar 24, 2015