Instrumental and Manual Increase of Couch in Neuromuscular Patients

Chronic Respiratory Failure Clinical Trial

— OPTICOUGH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518439
• Other study ID #: 2011-A00879-32
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: July 18, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Coughing
• Neuromuscular Disease
• Neuromuscular Diseases
• Respiratory Insufficiency

Intervention

Device:
• Alpha 200®
inspiratory capacity is increased with the use of constant pressure device: Alpha 200®
• 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 physiotherapist
• Cough Assist®
increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)
• 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 physiotherapist

Other:
• physiotherapist
manual pressures techniques to increase cough applied by the physiotherapist

Locations

Country	Name	City	State
France	RAYMOND POINCARE Hospital	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Adep Assistance

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cough flow obtained from the combination of mechanical and manual cough assistance techniques		2 Hours	No
Secondary	duration of efficient cough flow (above 180 l/min)under each cough assistance technique		2 Hours	No
Secondary	respiratory comfort	evaluation with a visual analogical scale	2 Hours	No
Secondary	subjective evaluation of cough efficiency	evaluation with a visual analogical scale	2 Hours	No
Secondary	Respiratory comfort	evaluation with the Borg dyspnea scale	2 Hours	No