Instrumental and Manual Increase of Couch in Neuromuscular Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01518439

Acronym

OPTICOUGH

Enrollment

Registered

2012-01-26

Start date

2012-01-31

Completion date

2013-07-31

Last updated

2013-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure, Coughing, Neuromuscular Disease

Keywords

neuromuscular, cough, restrictive

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.

Interventions

DEVICEAlpha 200®

inspiratory capacity is increased with the use of constant pressure device: Alpha 200®

DEVICEAlpha 200® + physiotherapist

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

DEVICECough Assist®

increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)

DEVICECough Assist® + physiotherapist

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

OTHERphysiotherapist

manual pressures techniques to increase cough applied by the physiotherapist

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
cough flow obtained from the combination of mechanical and manual cough assistance techniques	2 Hours

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026