Instrumental and Manual Increase of Couch in Neuromuscular Patients (OPTICOUGH)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Failure; Neuromuscular Disease; Coughing
• Intervention / Treatment: Device: Alpha 200®; Device: Alpha 200® + physiotherapist; Device: Cough Assist®; Device: Cough Assist® + physiotherapist; Other: physiotherapist

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Collaborators: Adep Assistance
• Investigators: Study Director: Frederic LOFASO, MD-PhD, University of Versailles; Principal Investigator: Helene Prigent, MD-PhD, University of Versailles

Publications and helpful links

General Publications

• 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:CD013170. doi: 10.1002/14651858.CD013170.pub2.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): July 19, 2013
• Last Update Submitted That Met QC Criteria: July 18, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: neuromuscular; cough; restrictive
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Neuromuscular Diseases
• Other Study ID Numbers: 2011-A00879-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No