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Completed

NCT Number: NCT01518439

Instrumental and Manual Increase of Couch in Neuromuscular Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAYMOND POINCARE Hospital

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha 200®

Device

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

Alpha 200® + physiotherapist

Device

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®

Device

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

Cough Assist® + physiotherapist

Device

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

physiotherapist

Other

manual pressures techniques to increase cough applied by the physiotherapist

Primary outcomes

  1. cough flow obtained from the combination of mechanical and manual cough assistance techniques

    Time frame: 2 Hours

Secondary outcomes

  1. duration of efficient cough flow (above 180 l/min)under each cough assistance technique

    Time frame: 2 Hours

  2. respiratory comfort

    Time frame: 2 Hours

    evaluation with a visual analogical scale

  3. subjective evaluation of cough efficiency

    Time frame: 2 Hours

    evaluation with a visual analogical scale

  4. Respiratory comfort

    Time frame: 2 Hours

    evaluation with the Borg dyspnea scale

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Collaborators

  • Adep Assistance

Registry information

Official study title

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

Acronym: OPTICOUGH

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jan 26, 2012
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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