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

This study has been completed.
Sponsor:
Collaborator:
Adep Assistance
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01518439
First received: January 11, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Neuromuscular Disease
Chronic Respiratory Failure
Coughing
Device: Alpha 200®
Device: Alpha 200® + physiotherapist
Device: Cough Assist®
Device: Cough Assist® + physiotherapist
Other: physiotherapist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • cough flow obtained from the combination of mechanical and manual cough assistance techniques [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of efficient cough flow (above 180 l/min)under each cough assistance technique [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
  • respiratory comfort [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
    evaluation with a visual analogical scale

  • subjective evaluation of cough efficiency [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
    evaluation with a visual analogical scale

  • Respiratory comfort [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]
    evaluation with the Borg dyspnea scale


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01518439

Locations
France
RAYMOND POINCARE Hospital
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Adep Assistance
Investigators
Study Director: Frederic Lofaso, Md-PhD University of Versailles
Principal Investigator: Helene Prigent, MD-PhD University of Versailles
  More Information

No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01518439     History of Changes
Other Study ID Numbers: 2011-A00879-32
Study First Received: January 11, 2012
Last Updated: July 18, 2013
Health Authority: France: Ministry of Health

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
neuromuscular
cough
restrictive

Additional relevant MeSH terms:
Respiratory Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014