Clinical trial NCT01518439: Instrumental and Manual Increase of Couch in Neuromuscular Patients
Official title: Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Disease
Chronic Respiratory Failure
Coughing
Keywords: neuromuscular
cough
restrictive
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Adep Assistance
First posted: 2012-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cough flow obtained from the combination of mechanical and manual cough assistance techniques
timeFrame: 2 Hours
Secondary outcomes:
measure: duration of efficient cough flow (above 180 l/min)under each cough assistance technique
timeFrame: 2 Hours
measure: respiratory comfort
timeFrame: 2 Hours
measure: subjective evaluation of cough efficiency
timeFrame: 2 Hours
measure: Respiratory comfort
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Garches
country: France
facility: RAYMOND POINCARE Hospital
Study officials:
affiliation: University of Versailles
name: Frederic Lofaso, Md-PhD
role: STUDY_DIRECTOR
affiliation: University of Versailles
name: Helene Prigent, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morrow B, Argent A, Zampoli M, Human A, Corten L, Toussaint M. Cough augmentation techniques for people with chronic neuromuscular disorders. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013170. doi: 10.1002/14651858.CD013170.pub2.