Intensive Care UnitSONOSTIMNCT04199273
Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking
A study testing Magnetic stimulation and Electric stimulation in people with Intensive Care Unit and Invasive Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Invasive Mechanical Ventilation
- What is being tested?
- Magnetic stimulation and Electric stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2019to 25 Aug 2022
- 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
- ICU patient with invasive mechanical ventilation
- Sedated patient with a Richmond Agitation-Sedation Scale of -4 or -5
Who cannot join
- Contraindication for magnetic stimulation (Pacemaker)
- Hemodynamic or respiratory instability : PaO2/FiO2 < 200 mmHg, noradrenaline > 0,3 µg/kg/min, dobutamine > 10 µg/kg/min
- Neuromuscular disease or recent use of neuromuscular blocking agents (2h30) with a TOF ratio below 4/4 95%.
- Refusal of study participation or to pursue the study by the patient, no consent
- Pregnancy or breastfeeding
- Absence of coverage by the French statutory healthcare insurance system
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire Saint Eloi
Montpellier, Herault, 34000
About this study
Official title: Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking : a Randomized, Cross Over, Physiologic Study in Critically Ill Patients Requiring Invasive Mechanical Ventilation
Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit
Read the detailed description
In intensive care unit, various forms of sepsis, undernutrition, surgery, global inflammation, iatrogeny, and mechanical ventilation, contribute to the overall muscular involvement including the diaphragm.
Assessment of diaphragm dysfunction is a critical issue for patients under mechanical ventilation, providing prognosis information and leading to the best therapeutic choices.
Up to now, for sedated ventilated critical care patient, expensive magnetic phrenic nerve stimulation equipment is needed to evaluate diaphragm strength.
In this study, the investigators aim to develop an affordable easy-to-use phrenic nerve stimulation tool, with ultrasonography and a nerve stimulator usually used for neuromuscular transmission monitoring. Hypothesis is that phrenic pacing using this new method is equivalent to the Gold Standard.
- Being tested
- Magnetic stimulation, Electric stimulation
- Keywords
- Intensive Care Unit, Invasive Mechanical Ventilation, Diaphragm weakness assessment, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stimulationProcedure or surgery
Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.
Electric stimulationProcedure or surgery
Cervical bilateral phrenic nerve stimulation after ultrasonography nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager)
| Study group | Role | What they receive |
|---|---|---|
| Magnetic stimulation and electric stimulation | Experimental | The patient receive first the magnetic stimulation with MagStim 200 tool. Then 15 min after he will receive the electric stimulation with the SonoStim tool : ultrasonography phrenic nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager) Receives: Procedure: Magnetic stimulation; Procedure: Electric stimulation |
| Electric stimulation and magnetic stimulation | Experimental | The patient receive first electric stimulation with the SonoStim tool : ultrasonography phrenic nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager). Then 15 min after he will receive the magnetic stimulation with MagStim 200 tool Receives: Procedure: Magnetic stimulation; Procedure: Electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal pressure (Ptrach) during diaphragm pacing
Negative pressure in the occluded breathing circuit, assessed with a manometer located just after the endotracheal tube, during diaphragm stimulation
Measured: During electric of magnetic phrenic nerve stimulation
Secondary outcomes (2)
Behavioral Pain Scale (BPS) after stimulation
The BPS is a scale of pain for critical care patients, from 3 (no or minimal pain) to 12 points (maximum pain).
Measured: Immediately after phrenic nerve stimulation
Distance in millimeter between anatomical and ultrasound phrenic nerve location
Distance between classical anatomical landmarks of the phrenic nerve location (underneath the posterior border of the sternocleidomastoid muscle, at the level of the cricoid cartilage), and the phrenic nerve location with ultrasound
Measured: During ultrasonography phrenic nerve tracking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start30 Oct 2019
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient, serving as their own control, receives both types of phrenic nerve stimulation : magnetic stimulation and electric stimulation. The order is randomized. For avoid a carry-over effect (diaphragm potentiation), a wash-out period of 15 minutes will be respected between the two type of stimulation.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jaber, MD, PHD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199273
- Sponsor's protocol ID
- RECHMPL19_0202
- Acronym
- SONOSTIM
- Status last verified
- Sep 2022
- First submitted
- 9 Dec 2019
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be made available upon a reasonable request
Publications
Capdevila M, De Jong A, Belafia F, Vonarb A, Carr J, Molinari N, Choquet O, Capdevila X, Jaber S. Ultrasound-guided Transcutaneous Phrenic Nerve Stimulation in Critically Ill Patients: A New Method to Evaluate Diaphragmatic Function. Anesthesiology. 2025 Mar 1;142(3):522-531. doi: 10.1097/ALN.0000000000005267. Epub 2024 Oct 21.
PubMed 39432817
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking : a Randomized, Cross Over, Physiologic Study in Critically Ill Patients Requiring Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04199273
- Acronym / sponsor ID
- SONOSTIM / RECHMPL19_0202
- Keywords
- Intensive Care Unit, Invasive Mechanical Ventilation, Diaphragm weakness assessment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 13 Dec 2019 (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.
Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit
Detailed description
In intensive care unit, various forms of sepsis, undernutrition, surgery, global inflammation, iatrogeny, and mechanical ventilation, contribute to the overall muscular involvement including the diaphragm.
Assessment of diaphragm dysfunction is a critical issue for patients under mechanical ventilation, providing prognosis information and leading to the best therapeutic choices.
Up to now, for sedated ventilated critical care patient, expensive magnetic phrenic nerve stimulation equipment is needed to evaluate diaphragm strength.
In this study, the investigators aim to develop an affordable easy-to-use phrenic nerve stimulation tool, with ultrasonography and a nerve stimulator usually used for neuromuscular transmission monitoring. Hypothesis is that phrenic pacing using this new method is equivalent to the Gold Standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient, serving as their own control, receives both types of phrenic nerve stimulation : magnetic stimulation and electric stimulation. The order is randomized. For avoid a carry-over effect (diaphragm potentiation), a wash-out period of 15 minutes will be respected between the two type of stimulation.
| Arm | Type | Receives |
|---|---|---|
| Magnetic stimulation and electric stimulation | Experimental | Procedure: Magnetic stimulation, Procedure: Electric stimulationThe patient receive first the magnetic stimulation with MagStim 200 tool. Then 15 min after he will receive the electric stimulation with the SonoStim tool : ultrasonography phrenic nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager) |
| Electric stimulation and magnetic stimulation | Experimental | Procedure: Magnetic stimulation, Procedure: Electric stimulationThe patient receive first electric stimulation with the SonoStim tool : ultrasonography phrenic nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager). Then 15 min after he will receive the magnetic stimulation with MagStim 200 tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICU patient with invasive mechanical ventilation
- Sedated patient with a Richmond Agitation-Sedation Scale of -4 or -5
Key exclusion criteria (6 listed)
- Contraindication for magnetic stimulation (Pacemaker)
- Hemodynamic or respiratory instability : PaO2/FiO2 < 200 mmHg, noradrenaline > 0,3 µg/kg/min, dobutamine > 10 µg/kg/min
- Neuromuscular disease or recent use of neuromuscular blocking agents (2h30) with a TOF ratio below 4/4 95%.
- Refusal of study participation or to pursue the study by the patient, no consent
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Magnetic stimulationCervical bilateral phrenic nerve stimulation with the MagStim 200 tool. | Procedure or surgery | Electric stimulation and magnetic stimulation, Magnetic stimulation and electric stimulation |
| Electric stimulationCervical bilateral phrenic nerve stimulation after ultrasonography nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager) | Procedure or surgery | Electric stimulation and magnetic stimulation, Magnetic stimulation and electric stimulation |
Primary outcome
Tracheal pressure (Ptrach) during diaphragm pacing
Time frame: During electric of magnetic phrenic nerve stimulation
Negative pressure in the occluded breathing circuit, assessed with a manometer located just after the endotracheal tube, during diaphragm stimulation
2 secondary outcomes
Behavioral Pain Scale (BPS) after stimulation
Time frame: Immediately after phrenic nerve stimulation
Distance in millimeter between anatomical and ultrasound phrenic nerve location
Time frame: During ultrasonography phrenic nerve tracking
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 16 Sep 2022.
- Derived from this study: PubMed 39432817Capdevila M, De Jong A, Belafia F, Vonarb A, Carr J, Molinari N, Choquet O, Capdevila X, Jaber S. Ultrasound-guided Transcutaneous Phrenic Nerve Stimulation in Critically Ill Patients: A New Method to Evaluate Diaphragmatic Function. Anesthesiology. 2025 Mar 1;142(3):522-531. doi: 10.1097/ALN.0000000000005267. Epub 2024 Oct 21.
- Individual participant dataSharing planned: Yes. Individual patient data will be made available upon a reasonable request
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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.
Samir Jaber, MD, PHD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic stimulation and Electric stimulation in people with Intensive Care Unit and Invasive Mechanical Ventilation, run by University Hospital, Montpellier 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 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: finished, as of the sponsor's last update on 16 Sep 2022. 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?
Tracheal pressure (Ptrach) during diaphragm pacing (time frame: During electric of magnetic phrenic nerve stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199273, which also lists 1 linked publication.
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 16 Sep 2022.