Instrumental and Manual Increase of Couch in Neuromuscular Patients (OPTICOUGH)
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|ClinicalTrials.gov Identifier: NCT01518439|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Disease Chronic Respiratory Failure Coughing||Device: Alpha 200® Device: Alpha 200® + physiotherapist Device: Cough Assist® Device: Cough Assist® + physiotherapist Other: physiotherapist||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||July 2013|
Experimental: neuromuscular patients
neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion
Device: Alpha 200®
inspiratory capacity is increased with the use of constant pressure device: Alpha 200®Device: Alpha 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 physiotherapistDevice: Cough Assist®
increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)Device: Cough 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 physiotherapistOther: physiotherapist
manual pressures techniques to increase cough applied by the physiotherapist
- cough flow obtained from the combination of mechanical and manual cough assistance techniques [ Time Frame: 2 Hours ]
- duration of efficient cough flow (above 180 l/min)under each cough assistance technique [ Time Frame: 2 Hours ]
- respiratory comfort [ Time Frame: 2 Hours ]evaluation with a visual analogical scale
- subjective evaluation of cough efficiency [ Time Frame: 2 Hours ]evaluation with a visual analogical scale
- Respiratory comfort [ Time Frame: 2 Hours ]evaluation with the Borg dyspnea scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518439
|RAYMOND POINCARE Hospital|
|Garches, France, 92380|
|Study Director:||Frederic Lofaso, Md-PhD||University of Versailles|
|Principal Investigator:||Helene Prigent, MD-PhD||University of Versailles|