DiaphragmADULTNCT03114384
Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography
A study testing Creation and detection of patient-respirator asynchronies in people with Diaphragm and Ultrasonography, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragm, Ultrasonography
- What is being tested?
- Creation and detection of patient-respirator asynchronies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2017to 30 Jul 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer (male or female)
- Free and Informed Consent
Who cannot join
- Known pregnancy, parturient or nursing mother
- Minor under 18 years of age
- Major incapable
- Non-affiliation to the social security scheme
- Any history of respiratory pathology
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Henri Mondor
Créteil, 94440
Armand Mekontso Dessap, Pr, + 33 1 49 81 23 94, armand.dessap@aphp.fr
CARTEAUX Guillaume, Dr
About this study
Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.
These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.
- Conditions
- Diaphragm, Ultrasonography
- Being tested
- Creation and detection of patient-respirator asynchronies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creation and detection of patient-respirator asynchroniesOther
The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Other: Creation and detection of patient-respirator asynchronies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchronies detection with diaphragm ultrasonography
Evaluation of the agreement between asynchronous subject-ventilator detection using diaphragm ultrasonography and detecting the same events in using the electromyogram of the respiratory muscles (as a reference technique.
Measured: thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start14 Apr 2017 (estimated)
- Primary completion30 Jul 2017 (estimated)
- Study completion30 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiaphragmStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114384
- Sponsor's protocol ID
- 2017-A00346-47
- Acronym
- ADULT
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography
- ClinicalTrials.gov ID
- NCT03114384
- Acronym / sponsor ID
- ADULT / 2017-A00346-47
- Conditions
- Diaphragm, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 14 Apr 2017 (estimated)
- Primary completion
- 30 Jul 2017 (estimated)
- Study completion
- 30 Jul 2017 (estimated)
- First posted
- 14 Apr 2017 (actual)
- 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.
Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.
These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Creation and detection of patient-respirator asynchronies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteer (male or female)
- Free and Informed Consent
Key exclusion criteria (5 listed)
- Known pregnancy, parturient or nursing mother
- Minor under 18 years of age
- Major incapable
- Non-affiliation to the social security scheme
- Any history of respiratory pathology
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 |
|---|---|---|
| Creation and detection of patient-respirator asynchroniesThe provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator | Other | Healthy volunteers |
Primary outcome
Asynchronies detection with diaphragm ultrasonography
Time frame: thirty minutes
Evaluation of the agreement between asynchronous subject-ventilator detection using diaphragm ultrasonography and detecting the same events in using the electromyogram of the respiratory muscles (as a reference technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creation and detection of patient-respirator asynchronies in people with Diaphragm and Ultrasonography, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Carteaux, Dr (+ 33 1 49 81 23 94, guillaume.carteaux@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchronies detection with diaphragm ultrasonography (time frame: thirty 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 14 Apr 2017.