Instrumental and Manual Increase of Couch in Neuromuscular Patients

Study Overview
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Brief Summary
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Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.

Detailed Description
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Hypothesis: Cough inefficiency in neuromuscular patients increases morbidity and mortality in case of airway infections and may lead to invasive ventilation. The use of techniques enhancing cough have been successful in improving the success of non invasive ventilation. We want to determine whether adding manual physiotherapist techniques to mechanical exsufflation improve cough efficiency and its ability to clear bronchial secretions. Objectives: To compare cough flows obtained with different combination of the use of increased inspiratory capacity technique, mechanical insufflation-exsufflation technique and manually applied pressures techniques. Method:open monocentric cross-over study (the patients are their own controls). Five combinations of cough increase techniques are compared Inclusion criteria: adult neuromuscular patients with a cough inefficiency at a stable state upon inclusion. As this is a pilot study, 20 patients from the home ventilation unit of the intensive care of the Raymond Poincare teaching hospital (Garches, France) will be included during the usual follow-up of chronic respiratory failure.

Official Title
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Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow

Conditions
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Neuromuscular Disease, Chronic Respiratory Failure, Coughing

Intervention / Treatment
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* Device: Alpha 200®
* Device: Alpha 200® + physiotherapist
* Device: Cough Assist®
* Device: Cough Assist® + physiotherapist
* Other: physiotherapist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients neuromuscular disorders with a respiratory restrictive syndrome (VC < 40% and/or cough flow < 180 L/min and/or Pe max < 40 cmH2O) non invasive ventilation stable respiratory state > 1 month before inclusion signed informed consent form Exclusion Criteria: unstable respiratory state with increased bronchial secretions unstable hemodynamics pneumothorax and or emphysema tracheostomy major bulbar involvement with swallowing dysfunction with the liquids Persons under Guardianship or Trusteeship Pregnant women not covered by the social security system refusal of study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neuromuscular patients<br>neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion | Device: Alpha 200®<br>* inspiratory capacity is increased with the use of constant pressure device: Alpha 200®<br>Device: Alpha 200® + physiotherapist<br>* inspiratory capacity is increased with the use of constant pressure device (Alpha 200®) combined with the manual pressures techniques to increase cough by the physiotherapist<br>Device: Cough Assist®<br>* increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)<br>Device: Cough Assist® + physiotherapist<br>* increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) combined with the manual pressures techniques to increase cough by the physiotherapist<br>Other: physiotherapist<br>* manual pressures techniques to increase cough applied by the physiotherapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough flow obtained from the combination of mechanical and manual cough assistance techniques |  | 2 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of efficient cough flow (above 180 l/min)under each cough assistance technique |  | 2 Hours | 
| respiratory comfort | evaluation with a visual analogical scale | 2 Hours | 
| subjective evaluation of cough efficiency | evaluation with a visual analogical scale | 2 Hours | 
| Respiratory comfort | evaluation with the Borg dyspnea scale | 2 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromuscular, cough, restrictive