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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02022072
Other study ID # 2013-A00218-37
Secondary ID
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


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
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