Acute Respiratory FailurePATCH-MMGNCT06046898
Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort
A study testing non-invasive ventilation with or without resistance in people with Acute Respiratory Failure, run by University Hospital, Angers at 1 site in France.
Trial summary
Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- non-invasive ventilation with or without resistance
- 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
- 6 Nov 2023to 26 Jun 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer
- Age > 18 and < 60
- Informed consent
- Fasting
- Subjects covered by or having the rights to medical care assurance
Who cannot join
- Obesity (BMI > 30 kg.m-2)
- Respiratory disease
- Cardiovascular disease
- Contraindication to the insertion of a nasogastric tube
- Incapacity to consent
- Pregnancy, breastfeeding
- Bad understanding of the French language,
- Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG
Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.
- Conditions
- Acute Respiratory Failure
- Being tested
- non-invasive ventilation with or without resistance
- Keywords
- Acute respiratory failure, Surface mechanomyography, Respiratory effort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilation with or without resistanceDevice
non-invasive ventilation with or without resistance.
| Study group | Role | What they receive |
|---|---|---|
| SV - R / SV + R / PSV | Experimental | Spontaneous ventilation without resistance (SV - R) / Spontaneous ventilation with resistance (SV + R) / Pressure support ventilation (PSV) Receives: Device: non-invasive ventilation with or without resistance |
| SV - R / PSV / SV + R | Experimental | Spontaneous ventilation without resistance / Pressure support ventilation / Spontaneous ventilation with resistance Receives: Device: non-invasive ventilation with or without resistance |
| SV + R / PSV / SV - R | Experimental | Spontaneous ventilation with resistance / Pressure support ventilation / Spontaneous ventilation without resistance Receives: Device: non-invasive ventilation with or without resistance |
| SV + R / SV - R / PSV | Experimental | Spontaneous ventilation with resistance / Spontaneous ventilation without resistance / Pressure support ventilation Receives: Device: non-invasive ventilation with or without resistance |
| PSV / SV + R / SV - R | Experimental | Pressure support ventilation / Spontaneous ventilation with resistance / Spontaneous ventilation without resistance Receives: Device: non-invasive ventilation with or without resistance |
| PSV / SV - R / SV + R | Experimental | Pressure support ventilation / Spontaneous ventilation without resistance / Spontaneous ventilation with resistance Receives: Device: non-invasive ventilation with or without resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of sMMG to detect respiratory effort
Delays between the beginning of the respiratory effort detected by sMMG and Eadi and the end of the respiratory effort detected by sMMG and Eadi (msec)
Measured: 5 minutes after the beginning of recording
Secondary outcomes (4)
Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak
Accuracy of sMMG to assess the intensity of respiratory effort (in comparison with pressure-time product in cm H2O.s.min-1)
Measured: 5 minutes after the beginning of recording
Comparison between sMMG slope & Eadi parameters
Accuracy of sMMG to assess the intensity of respiratory drive (in comparison with Eadi in microvolt)
Measured: 5 minutes after the beginning of recording
Comparison between sMMG slope & slope Peso
Accuracy of sMMG to assess the intensity of respiratory drive (in comparison Peso in cm H20)
Measured: 5 minutes after the beginning of recording
Delay between neural time measured by sMMG and neural time measured by Eadi
Accuracy of sMMG to assess the duration of inspiratory neural time (in comparison with Eadi in msec)
Measured: 5 minutes after the beginning of recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start6 Nov 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- Esophageal pressure, electrical activity of the diaphram (Eadi) and sMMG will be recorded in 10 healthy subjects in spontaneous ventilation (SV) and non-invasive ventilation with or without resistance.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046898
- Sponsor's protocol ID
- 49RC22_0395
- Acronym
- PATCH-MMG
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort in Healthy Volunteers - PATCH-MMG
- ClinicalTrials.gov ID
- NCT06046898
- Acronym / sponsor ID
- PATCH-MMG / 49RC22_0395
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute respiratory failure, Surface mechanomyography, Respiratory effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 21 Sep 2023 (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.
Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Esophageal pressure, electrical activity of the diaphram (Eadi) and sMMG will be recorded in 10 healthy subjects in spontaneous ventilation (SV) and non-invasive ventilation with or without resistance.
| Arm | Type | Receives |
|---|---|---|
| SV - R / SV + R / PSV | Experimental | Device: non-invasive ventilation with or without resistanceSpontaneous ventilation without resistance (SV - R) / Spontaneous ventilation with resistance (SV + R) / Pressure support ventilation (PSV) |
| SV - R / PSV / SV + R | Experimental | Device: non-invasive ventilation with or without resistanceSpontaneous ventilation without resistance / Pressure support ventilation / Spontaneous ventilation with resistance |
| SV + R / PSV / SV - R | Experimental | Device: non-invasive ventilation with or without resistanceSpontaneous ventilation with resistance / Pressure support ventilation / Spontaneous ventilation without resistance |
| SV + R / SV - R / PSV | Experimental | Device: non-invasive ventilation with or without resistanceSpontaneous ventilation with resistance / Spontaneous ventilation without resistance / Pressure support ventilation |
| PSV / SV + R / SV - R | Experimental | Device: non-invasive ventilation with or without resistancePressure support ventilation / Spontaneous ventilation with resistance / Spontaneous ventilation without resistance |
| PSV / SV - R / SV + R | Experimental | Device: non-invasive ventilation with or without resistancePressure support ventilation / Spontaneous ventilation without resistance / Spontaneous ventilation with resistance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy volunteer
- Age > 18 and < 60
- Informed consent
- Fasting
- Subjects covered by or having the rights to medical care assurance
Key exclusion criteria (8 listed)
- Obesity (BMI > 30 kg.m-2)
- Respiratory disease
- Cardiovascular disease
- Contraindication to the insertion of a nasogastric tube
- Incapacity to consent
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 |
|---|---|---|
| non-invasive ventilation with or without resistancenon-invasive ventilation with or without resistance. | Device | PSV / SV + R / SV - R, PSV / SV - R / SV + R, SV + R / PSV / SV - R, SV + R / SV - R / PSV, SV - R / PSV / SV + R, SV - R / SV + R / PSV |
Primary outcome
Accuracy of sMMG to detect respiratory effort
Time frame: 5 minutes after the beginning of recording
Delays between the beginning of the respiratory effort detected by sMMG and Eadi and the end of the respiratory effort detected by sMMG and Eadi (msec)
4 secondary outcomes
Comparison between sMMG-time (MMG-TP) and PTPes-Pes Peak
Time frame: 5 minutes after the beginning of recording
Comparison between sMMG slope & Eadi parameters
Time frame: 5 minutes after the beginning of recording
Comparison between sMMG slope & slope Peso
Time frame: 5 minutes after the beginning of recording
Delay between neural time measured by sMMG and neural time measured by Eadi
Time frame: 5 minutes after the beginning of recording
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 3 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 study testing non-invasive ventilation with or without resistance in people with Acute Respiratory Failure, run by University Hospital, Angers 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 8 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 3 Mar 2025. 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?
Accuracy of sMMG to detect respiratory effort (time frame: 5 minutes after the beginning of recording). 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 3 Mar 2025.