Neuromuscular DisorderPHONOVNINCT01819090
Optimizing Communication During Ventilation
A study testing Elysee 150 ventilator in people with Neuromuscular Disorder and Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disorder, Respiratory Failure
- What is being tested?
- Elysee 150 ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with restrictive respiratory failure secondary to a neuromuscular disorder, without any bulbar involvement.
- Age greater than or equal to 18.
- Hospitalization in Home Ventilation Unit of the intensive care department of R. Poincaré Hospital.
- Non invasive mechanical ventilation for a duration equal or above 14h per day.
- Patient in a steady state at the time of the study
- written informed consent
Who cannot join
- patient's refusal to participate to the study
- Inability to read the selected text
- Inability to use the ventilator switch
- Inability to cooperate
- Hemodynamic instability
- Acute respiratory failure
- No affiliation to social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Communication During Nasal Mechanical Ventilation
Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.
- Conditions
- Neuromuscular Disorder, Respiratory Failure
- Being tested
- Elysee 150 ventilator, Elysee 150 ventilator with a ventilation switch control
- Keywords
- Neuromuscular disorder, Mechanical ventilation, Speech, Respiratory failure
- Medical subject headings
- Neuromuscular Diseases, Respiratory Insufficiency, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elysee 150 ventilatorDevice
Also called Elysee 150 - Resmed
Elysee 150 ventilator with a ventilation switch controlDevice
Also called Elysee 150 ventilator - Resmed - with a ventilation switch control
| Study group | Role | What they receive |
|---|---|---|
| No ventilation switch control | Active comparator | Neuromuscular patients non invasively ventilated in a stable state at the time of the study testing an usual (with no ventilation switch control) Elysee 150 ventilator while speaking Receives: Device: Elysee 150 ventilator |
| Ventilation switch control | Active comparator | Neuromuscular patients non invasively ventilated in a stable state at the time of the study testing an Elysee 150 ventilator with a ventilation switch control allowing them to control ventilation while speaking Receives: Device: Elysee 150 ventilator with a ventilation switch control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of patient's ventilation control on speech efficiency
Speech efficiency will be evaluated while using a ventilator which allows the patient to constantly control when he wants to be ventilated Speech evaluation is based on speech rhythm and text reading duration
Measured: 1 hour 30 min
Secondary outcomes (4)
Patient ventilator synchronisation during speech
Evaluated with the variation of respiratory frequency during speech, the number of auto-triggered ventilation cycles during speech.
Measured: 1hour 30 min
User friendliness of the ventilator during speech
evaluation of user friendliness by the patient using a visual analogical score
Measured: 1hour 30 min
Respiratory comfort during speech
evaluation of user friendliness by the patient using a visual analogical score and the Borg score
Measured: 1hour 30 min
Speech comfort during ventilation
evaluation of speech comfort during ventilation by the patient using a visual analogical score
Measured: 1hour 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Prigent, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Helene PRIGENT, MDPHD, Principal investigator, Hôpital RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819090
- Sponsor's protocol ID
- 2012- A01394-39
- Acronym
- PHONOVNI
- Status last verified
- Oct 2015
- First submitted
- 7 Mar 2013
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Communication During Nasal Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01819090
- Acronym / sponsor ID
- PHONOVNI / 2012- A01394-39
- Conditions
- Neuromuscular Disorder, Respiratory Failure
- Keywords
- Neuromuscular disorder, Mechanical ventilation, Speech, Respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Mar 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.
Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No ventilation switch control | Active comparator | Device: Elysee 150 ventilatorNeuromuscular patients non invasively ventilated in a stable state at the time of the study testing an usual (with no ventilation switch control) Elysee 150 ventilator while speaking |
| Ventilation switch control | Active comparator | Device: Elysee 150 ventilator with a ventilation switch controlNeuromuscular patients non invasively ventilated in a stable state at the time of the study testing an Elysee 150 ventilator with a ventilation switch control allowing them to control ventilation while speaking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with restrictive respiratory failure secondary to a neuromuscular disorder, without any bulbar involvement.
- Age greater than or equal to 18.
- Hospitalization in Home Ventilation Unit of the intensive care department of R. Poincaré Hospital.
- Non invasive mechanical ventilation for a duration equal or above 14h per day.
- Patient in a steady state at the time of the study
Key exclusion criteria (7 listed)
- patient's refusal to participate to the study
- Inability to read the selected text
- Inability to use the ventilator switch
- Inability to cooperate
- Hemodynamic instability
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 |
|---|---|---|
| Elysee 150 ventilatorAlso: Elysee 150 - Resmed | Device | No ventilation switch control |
| Elysee 150 ventilator with a ventilation switch controlAlso: Elysee 150 ventilator - Resmed - with a ventilation switch control | Device | Ventilation switch control |
Primary outcome
Impact of patient's ventilation control on speech efficiency
Time frame: 1 hour 30 min
Speech efficiency will be evaluated while using a ventilator which allows the patient to constantly control when he wants to be ventilated Speech evaluation is based on speech rhythm and text reading duration
4 secondary outcomes
Patient ventilator synchronisation during speech
Time frame: 1hour 30 min
User friendliness of the ventilator during speech
Time frame: 1hour 30 min
Respiratory comfort during speech
Time frame: 1hour 30 min
Speech comfort during ventilation
Time frame: 1hour 30 min
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 15 Feb 2016.
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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.
Helene PRIGENT, MDPHD principal investigator
Hôpital RAYMOND POINCARE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elysee 150 ventilator in people with Neuromuscular Disorder and Respiratory Failure, 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 6 inclusion and 7 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 15 Feb 2016. 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?
Impact of patient's ventilation control on speech efficiency (time frame: 1 hour 30 min). 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 15 Feb 2016.