Instrumental and Manual Increase of Couch in Neuromuscular Patients (OPTICOUGH)

Centre d'Investigation Clinique et Technologique 805

Status: Completed

Conditions: Chronic Respiratory Failure; Coughing; Neuromuscular Disease

Treatments: Device: Alpha 200® + physiotherapist; Device: Alpha 200®; Device: Cough Assist®; Other: physiotherapist; Device: Cough Assist® + physiotherapist

Study type: Interventional

Funder types: Other

Identifiers

NCT01518439

2011-A00879-32

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

neuromuscular patients

Experimental group

Description:

neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion

Treatment:

Device: Alpha 200® + physiotherapist

Device: Alpha 200®

Other: physiotherapist

Device: Cough Assist® + physiotherapist

Device: Cough Assist®