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Evaluation of Vital Capacity (CVassist)

This study has been terminated.
(With 50 patients, the measure of assist vital capacity has been validated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02022072
First Posted: December 27, 2013
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022072


Locations
France
Hôpital R Poincare
Garches, France
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
  More Information

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02022072     History of Changes
Other Study ID Numbers: 2013-A00218-37
First Submitted: November 5, 2013
First Posted: December 27, 2013
Last Update Posted: July 28, 2015
Last Verified: July 2015

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