Evaluation of Vital Capacity (CVassist)

Centre d'Investigation Clinique et Technologique 805

Status and phase

Terminated

Phase 2

Conditions

Respiration Disorders

Neuromuscular Disease

Treatments

Device: measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)

Study type

Interventional

Funder types

Other

Identifiers

NCT02022072

2013-A00218-37

Details and patient eligibility

About

Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital capacity (VC) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. The methodology consists in realize VC by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. The study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

consent form signature
Men and women aged over or equal to 18 years old
Medical examination before the research
Negative results of tests of pregnancy for the women at age to procreate or taking an effective contraceptive
Patients with neuromuscular pathologies without tracheostmy - Vital Capacity < 80% of theoretical value

Exclusion criteria

Refuse to participate at the research
Patient under guardianship or under trusteeship
pregnant Women
Patients unable to cooperate
Patients without a security social scheme (as beneficiary or bearer of rights)
Usual contra-indications for an insufflation (haemoptise, recent pneumothorax, pulmonary emphysema, pleuresy, nausea, chronic obstructive pulmonary diseasee or asthma, recent lobectomy, intracranial hypertension, troubles of consciousness, unable to talk)