General AnaesthesiaSTIMIT-INCT04946110
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients
A study testing Electromagnetic stimulation in people with General Anaesthesia and Muscle Weakness, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anaesthesia, Muscle Weakness
- What is being tested?
- Electromagnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jul 2021to 29 Jul 2021
- 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
- ≥ 18 years of age
- American Society of Anaesthesiologists Classification I or II
Who cannot join
- Chronic lung disease
- Preexisting diaphragmatic weakness
- Neurologic disease with known motor weakness
- Paralysis of the phrenic nerve
- Contraindication for any movement in the cervical vertebrae
- Conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure, adipositas.
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- Inability to communicate in the official language
- Infections, lesions or stricture in the neck area
- Implanted cardiac devices e.g. pace maker, defibrillator, event recorder
- Implanted medical pumps e.g. left ventricular assist device
- Metal implants in the upper body
- Preganancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.
Read the detailed description
During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.
Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.
- Conditions
- General Anaesthesia, Muscle Weakness
- Being tested
- Electromagnetic stimulation
- Keywords
- VIDD, ICUAW, muscle weakness
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic stimulationDevice
Electromagnetic stimulation of the phrenic nerve
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic stimulation | Experimental | Electromagnetic stimulation of the phrenic nerve. Receives: Device: Electromagnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
Measured: Study duration (approximately 10 minutes)
Secondary outcomes (12)
Tidal volume per breath
Tidal volume
Measured: Study duration (approximately 10 minutes)
Max inspiratory flow after stimulation
The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)
Measured: Study duration (approximately 10 minutes)
Abdominal extension maximum
Extension of the abdomen measured via in abdominal belt
Measured: Study duration (approximately 10 minutes)
Air pressure during each breath
Change in pressure in the duct from expiration to inspiration (mbar)
Measured: Study duration (approximately 10 minutes)
Diaphragmatic thickening fraction
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
Measured: Study duration (approximately 10 minutes)
Feedback/Stimulation locus relation
When the stimulation locus is changed according to protocol the change of the triggered breath is measured in % to the original location.
Measured: Study duration (approximately 10 minutes)
Latency between stimulation and feedback
Time between start and end of the stimulation in seconds
Measured: Study duration (approximately 10 minutes)
Intensity/Contractility relation
Correlation between the simulation intensity and the diaphragmatic contractility
Measured: Study duration (approximately 10 minutes)
Time to find the optimal stimulation point of the N. phrenicus
Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
Measured: Study duration (approximately 10 minutes)
Distance between anatomical landmarks and optimal stimulation locus
Distance between anatomical landmarks and optimal stimulation locus
Measured: Study duration (approximately 10 minutes)
Reproducibility of stimulation answer
Variation of stimulated tidal volumes and diaphragm contraction
Measured: Study duration (approximately 10 minutes)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events elicited by the electromagnetic stimulation
Measured: Study duration (approximately 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start13 Jul 2021
- Primary completion29 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Stimit AG
- Responsible party
- Principal investigator, Stefan J Schaller, Charite University, Berlin, Germany
- Investigators
- Stefan J Schaller, Prof. Dr., Principal investigator, Charité - Universitätsmedizin Berlin, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946110
- Sponsor's protocol ID
- STIMIT-I
- Acronym
- STIMIT-I
- Status last verified
- Oct 2021
- First submitted
- 17 Mar 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be requested on reasonable scientific request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT04946110
- Acronym / sponsor ID
- STIMIT-I / STIMIT-I
- Conditions
- General Anaesthesia, Muscle Weakness
- Keywords
- VIDD, ICUAW, muscle weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Stimit AG
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 30 Jun 2021 (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.
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.
Detailed description
During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.
Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.
In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic stimulation | Experimental | Device: Electromagnetic stimulationElectromagnetic stimulation of the phrenic nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- American Society of Anaesthesiologists Classification I or II
Key exclusion criteria (12 listed)
- Chronic lung disease
- Preexisting diaphragmatic weakness
- Neurologic disease with known motor weakness
- Paralysis of the phrenic nerve
- Contraindication for any movement in the cervical vertebrae
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 |
|---|---|---|
| Electromagnetic stimulationElectromagnetic stimulation of the phrenic nerve | Device | Electromagnetic stimulation |
Primary outcome
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
Time frame: Study duration (approximately 10 minutes)
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
12 secondary outcomes
Tidal volume per breath
Time frame: Study duration (approximately 10 minutes)
Max inspiratory flow after stimulation
Time frame: Study duration (approximately 10 minutes)
Abdominal extension maximum
Time frame: Study duration (approximately 10 minutes)
Air pressure during each breath
Time frame: Study duration (approximately 10 minutes)
Diaphragmatic thickening fraction
Time frame: Study duration (approximately 10 minutes)
Feedback/Stimulation locus relation
Time frame: Study duration (approximately 10 minutes)
Latency between stimulation and feedback
Time frame: Study duration (approximately 10 minutes)
Intensity/Contractility relation
Time frame: Study duration (approximately 10 minutes)
Time to find the optimal stimulation point of the N. phrenicus
Time frame: Study duration (approximately 10 minutes)
Distance between anatomical landmarks and optimal stimulation locus
Time frame: Study duration (approximately 10 minutes)
Reproducibility of stimulation answer
Time frame: Study duration (approximately 10 minutes)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Study duration (approximately 10 minutes)
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 27 Oct 2021.
- Individual participant dataSharing planned: Yes. Deidentified data can be requested on reasonable scientific 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.
Stefan J Schaller, Prof. Dr. principal investigator
Charité - Universitätsmedizin Berlin, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic stimulation in people with General Anaesthesia and Muscle Weakness, run by Charite University, Berlin, Germany at 1 site in Germany.
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 12 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 27 Oct 2021. 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 Germany. 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?
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) (time frame: Study duration (approximately 10 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 27 Oct 2021.