Evaluation of Vital Capacity (CVassist)

This study has been terminated.
(With 50 patients, the measure of assist vital capacity has been validated)
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 27, 2015
Last verified: July 2015
  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
Respiration Disorders
Neuromuscular Disease
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
Official Title: Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases

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 ]

Enrollment: 66
Study Start Date: May 2013
Study Completion Date: April 2015
Primary Completion Date: October 2014 (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®)
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

Locations
France
Hôpital R Poincare
Garches, France
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 27, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neuromuscular Diseases
Respiration Disorders
Nervous System Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 03, 2015