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| Name | Class |
|---|---|
| Stimit AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electromagnetic stimulation | Experimental | Electromagnetic stimulation of the phrenic nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromagnetic stimulation | Device | Electromagnetic stimulation of the phrenic nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) | Mean tidal volume of 10 consecutively stimulations of the phrenic nerve | Study duration (approximately 10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume per breath | Tidal volume | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan J Schaller, Prof. Dr. | Charité - Universitätsmedizin Berlin, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Univiversitätsmedizin Berlin | Berlin | 10117 | Germany |
Deidentified data can be requested on reasonable scientific request.
After publication of scientific manuscript.
Deidentified data can be requested on reasonable scientific request.
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| Study duration (approximately 10 minutes) |
| Abdominal extension maximum | Extension of the abdomen measured via in abdominal belt | Study duration (approximately 10 minutes) |
| Air pressure during each breath | Change in pressure in the duct from expiration to inspiration (mbar) | Study duration (approximately 10 minutes) |
| Diaphragmatic thickening fraction | Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation | 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. | Study duration (approximately 10 minutes) |
| Latency between stimulation and feedback | Time between start and end of the stimulation in seconds | Study duration (approximately 10 minutes) |
| Intensity/Contractility relation | Correlation between the simulation intensity and the diaphragmatic contractility | 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 | Study duration (approximately 10 minutes) |
| Distance between anatomical landmarks and optimal stimulation locus | Distance between anatomical landmarks and optimal stimulation locus | Study duration (approximately 10 minutes) |
| Reproducibility of stimulation answer | Variation of stimulated tidal volumes and diaphragm contraction | Study duration (approximately 10 minutes) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse Events elicited by the electromagnetic stimulation | Study duration (approximately 10 minutes) |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |