Evaluation of Vital Capacity

Neuromuscular Disease Clinical Trial

— CVassist  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02022072
• Other study ID #: 2013-A00218-37
• Status: Terminated
• Phase: Phase 2
• First received: November 5, 2013
• Last updated: July 27, 2015
• Start date: May 2013
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases
• Respiration Disorders

Intervention

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

Locations

Country	Name	City	State
France	Hôpital R Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.		30 minutes	No