Evaluation of Vital Capacity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiration Disorders Neuromuscular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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measure of assisted vital capacity by mechanical insufflation

measure of assisted vital capacity by a mechanical insufflation/exsufflation

Group Type OTHER

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

Intervention Type DEVICE

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

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes