Evaluation of Vital Capacity

Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02022072

Acronym

CVassist

Enrollment

Registered

2013-12-27

Start date

2013-05-31

Completion date

2015-04-30

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Disease, Respiration Disorders

Brief summary

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.

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.	30 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026