Evaluation of Vital Capacity

NCT02022072 | Terminated Phase 2

• 1 other identifier: 2013-A00218-37
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration Disorders; Neuromuscular Disease

Outcome Measures

Primary Outcomes (1)

• Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.

  30 minutes

Study Arms (1)

measure of assisted vital capacity by mechanical insufflation

OTHER

measure of assisted vital capacity by a mechanical insufflation/exsufflation

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

Interventions

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

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

measure of assisted vital capacity by mechanical insufflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Hôpital R Poincare

Garches, France

Location

MeSH Terms

Conditions

Respiration Disorders; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: December 27, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: April 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

FR (1)