Back to resultsEvaluation of Vital Capacity (CVassist)
Primary Purpose
Respiration Disorders, Neuromuscular Disease
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
Sponsored by
About this trial
This is an interventional supportive care trial for Respiration Disorders
Eligibility 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)
Sites / Locations
- Hôpital R Poincare
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
measure of assisted vital capacity by mechanical insufflation
Arm Description
measure of assisted vital capacity by a mechanical insufflation/exsufflation
Outcomes
Primary Outcome Measures
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
Secondary Outcome Measures
Full Information
NCT ID
NCT02022072
First Posted
November 5, 2013
Last Updated
July 27, 2015
Sponsor
Centre d'Investigation Clinique et Technologique 805
1. Study Identification
Unique Protocol Identification Number
NCT02022072
Brief Title
Evaluation of Vital Capacity
Acronym
CVassist
Official Title
Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
With 50 patients, the measure of assist vital capacity has been validated
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Disorders, Neuromuscular Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
measure of assisted vital capacity by mechanical insufflation
Arm Type
Other
Arm Description
measure of assisted vital capacity by a mechanical insufflation/exsufflation
Intervention Type
Device
Intervention Name(s)
measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
Intervention Description
measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
Primary Outcome Measure Information:
Title
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Hôpital R Poincare
City
Garches
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Vital Capacity
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