Instrumental and Manual Increase of Couch in Neuromuscular Patients

NCT ID: NCT01518439

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-07-31

Brief 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.

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.

Conditions

Neuromuscular Disease; Chronic Respiratory Failure; Coughing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neuromuscular patients

neuromuscular patients with cough inefficiency in a stable respiratory state upon inclusion

Group Type: EXPERIMENTAL

Alpha 200®

Intervention Type: DEVICE

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

Alpha 200® + physiotherapist

Intervention Type: 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®

Intervention Type: DEVICE

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

Cough Assist® + physiotherapist

Intervention Type: 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

Intervention Type: OTHER

manual pressures techniques to increase cough applied by the physiotherapist

Interventions

Alpha 200®

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

Intervention Type: 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

Intervention Type: DEVICE

Cough Assist®

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

Intervention Type: 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

Intervention Type: DEVICE

physiotherapist

manual pressures techniques to increase cough applied by the physiotherapist

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adep Assistance

OTHER

Sponsor Role: collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic Lofaso, Md-PhD

Role: STUDY_DIRECTOR

University of Versailles

Helene Prigent, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University of Versailles

Locations

RAYMOND POINCARE Hospital

Garches, Garches, France

Countries

France

References

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(4):CD013170. doi: 10.1002/14651858.CD013170.pub2.

Reference Type: DERIVED

PMID: 33887060 (View on PubMed)

Other Identifiers

2011-A00879-32

Identifier Type: -

Identifier Source: org_study_id