Respiration DisordersPhase 2CVassistNCT02022072
Evaluation of Vital Capacity
A Phase 2 study testing measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®) in people with Respiration Disorders and Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiration Disorders, Neuromuscular Disease
- What is being tested?
- measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases
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.
- Conditions
- Respiration Disorders, Neuromuscular Disease
- Being tested
- measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
- Medical subject headings
- Respiration Disorders, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)Device
measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
| Study group | Role | What they receive |
|---|---|---|
| measure of assisted vital capacity by mechanical insufflation | Other | measure of assisted vital capacity by a mechanical insufflation/exsufflation Receives: Device: measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionApr 2015
Why it stopped: With 50 patients, the measure of assist vital capacity has been validated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022072
- Sponsor's protocol ID
- 2013-A00218-37
- Acronym
- CVassist
- Status last verified
- Jul 2015
- First submitted
- 5 Nov 2013
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT02022072
- Acronym / sponsor ID
- CVassist / 2013-A00218-37
- Conditions
- Respiration Disorders, Neuromuscular Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: With 50 patients, the measure of assist vital capacity has been validated
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measure of assisted vital capacity by mechanical insufflation | Other | Device: measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)measure of assisted vital capacity by a mechanical insufflation/exsufflation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®) | Device | measure of assisted vital capacity by mechanical insufflation |
Primary outcome
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: With 50 patients, the measure of assist vital capacity has been validated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®) in people with Respiration Disorders and Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: With 50 patients, the measure of assist vital capacity has been validated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.