Evaluation of Vital Capacity (CVassist)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT02022072
First received: November 5, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Analysis of the Muscular Causes of Restrictive Syndrome in Neuromuscular Diseases
Device: measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
measure of assisted vital capacity by mechanical insufflation
measure of assisted vital capacity by a mechanical insufflation/exsufflation
Device: measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022072

Contacts
Contact: Pr Lofaso

Locations
France
Hôpital R Poincare Recruiting
Garches, France
Contact: Frederic Lofaso, PrD       f.lofaso@rpc.aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
  More Information

No publications provided

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02022072     History of Changes
Other Study ID Numbers: 2013-A00218-37
Study First Received: November 5, 2013
Last Updated: July 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014