Instrumental and Manual Increase of Couch in Neuromuscular Patients

Not Applicable

Completed

• Conditions: Neuromuscular Disease; Chronic Respiratory Failure; Coughing
• Interventions: Device: Alpha 200®; Device: Alpha 200® + physiotherapist; Device: Cough Assist®; Device: Cough Assist® + physiotherapist; Other: physiotherapist

• Registration Number: NCT01518439
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-18
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neuromuscular patients	Alpha 200®	neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
neuromuscular patients	Alpha 200® + physiotherapist	neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
neuromuscular patients	Cough Assist®	neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
neuromuscular patients	Cough Assist® + physiotherapist	neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
neuromuscular patients	physiotherapist	neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion

Primary Outcome Measures

Name	Time	Method
cough flow obtained from the combination of mechanical and manual cough assistance techniques	2 Hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

RAYMOND POINCARE Hospital; 🇫🇷 Garches, France