Clinical trial NCT02236104: Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
Official title: Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Insufflation-exsufflation Session ( With Cough Assist)
Keywords: neuromuscular disorders
mechanical insufflation-exsufflation
respiratory parameters
plethysmography opto electronic
Vital capacity
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: University of Versailles
First posted: 2014-09-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pulmonary disorder
* Acute respiratory failure
* Cognitive deficit

Primary outcomes:
measure: maximal inspiratory pressures
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincaré
Study officials:
affiliation: Raymond poincare hospital
name: Frederic LOFASO, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Raymond Poincare hospital
name: Michel Petitjean, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: