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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02236104
Acronym
coughassistAFM
Enrollment
16
Registered
2014-09-10
Start date
2010-11-30
Completion date
2014-01-31
Last updated
2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Insufflation-exsufflation Session ( With Cough Assist)

Keywords

neuromuscular disorders, mechanical insufflation-exsufflation, respiratory parameters, plethysmography opto electronic, Vital capacity

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.

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.

Interventions

DEVICEPlethysmography opto electronic
PROCEDURErespiratory parameters

Sponsors

University of Versailles
CollaboratorOTHER
Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
maximal inspiratory pressures2 hoursmeasure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026