Mechanical Insufflation-exsufflation Session ( With Cough Assist)coughassistAFMNCT02236104
Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
A study testing Plethysmography opto electronic and respiratory parameters in people with Mechanical Insufflation-exsufflation Session ( With Cough Assist), run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mechanical Insufflation-exsufflation Session ( With Cough Assist)
- What is being tested?
- Plethysmography opto electronic and respiratory parameters
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jan 2014
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged more than 18 years
- Written consents
- Neuromuscular disorders
- Hemodynamic stability
Who cannot join
- Pulmonary disorder
- Acute respiratory failure
- Cognitive deficit
Trial locations and contacts
1 site in 1 country.
About this study
A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.
Read the detailed description
30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches, France).
Respiratory parameters and comfort will be evaluated before and after (5min,
1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern will be recorded allowing the measurements of respiratory frequency, tidal volume, Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of tension-time index (TT0.1).
Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse oxymetry.
Respiratory comfort will be assessed with a visual analog scale. Optoelectronic plethysmography will be use to perform regional ventilation evaluation. Using chest wall motion analysis we will compute respiratory participation of upper, lower thorax and abdomen, right and left side.
Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms of action of MI-E on respiration and chest-wall motion will be analysed and the persistence of the beneficial effect of MI-E will be assessed.
- Being tested
- Plethysmography opto electronic, respiratory parameters
- Keywords
- neuromuscular disorders, mechanical insufflation-exsufflation, respiratory parameters, plethysmography opto electronic, Vital capacity
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plethysmography opto electronicDevice
respiratory parametersProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| cough assist session | Experimental | Mechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O. Receives: Device: Plethysmography opto electronic; Procedure: respiratory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal inspiratory pressures
measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Insufflation-exsufflation Session ( With Cough Assist)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- University of Versailles
- Responsible party
- Sponsor
- Investigators
- Frederic LOFASO, MD PHD, Principal investigator, Raymond poincare hospitalMichel Petitjean, MDPHD, Principal investigator, Raymond Poincare hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236104
- Sponsor's protocol ID
- 2010-A01042-37
- Acronym
- coughassistAFM
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.
- ClinicalTrials.gov ID
- NCT02236104
- Acronym / sponsor ID
- coughassistAFM / 2010-A01042-37
- Keywords
- neuromuscular disorders, mechanical insufflation-exsufflation, respiratory parameters, plethysmography opto electronic, Vital capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- University of Versailles
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Sep 2014 (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.
A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.
Detailed description
30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches, France).
Respiratory parameters and comfort will be evaluated before and after (5min,
1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern will be recorded allowing the measurements of respiratory frequency, tidal volume, Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of tension-time index (TT0.1).
Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse oxymetry.
Respiratory comfort will be assessed with a visual analog scale. Optoelectronic plethysmography will be use to perform regional ventilation evaluation. Using chest wall motion analysis we will compute respiratory participation of upper, lower thorax and abdomen, right and left side.
Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms of action of MI-E on respiration and chest-wall motion will be analysed and the persistence of the beneficial effect of MI-E will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cough assist session | Experimental | Device: Plethysmography opto electronic, Procedure: respiratory parametersMechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged more than 18 years
- Written consents
- Neuromuscular disorders
- Hemodynamic stability
Key exclusion criteria (3 listed)
- Pulmonary disorder
- Acute respiratory failure
- Cognitive deficit
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 |
|---|---|---|
| Plethysmography opto electronic | Device | cough assist session |
| respiratory parameters | Procedure or surgery | cough assist session |
Primary outcome
maximal inspiratory pressures
Time frame: 2 hours
measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
Frederic LOFASO, MD PHD principal investigator
Raymond poincare hospital
Michel Petitjean, MDPHD principal investigator
Raymond Poincare hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plethysmography opto electronic and respiratory parameters in people with Mechanical Insufflation-exsufflation Session ( With Cough Assist), 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 24 Mar 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximal inspiratory pressures (time frame: 2 hours). 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 24 Mar 2015.