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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 in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
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 in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention, stimulated | Experimental | Electromagnetic stimulation of the phrenic nerve in critically ill patients. |
|
| Control, not stimulated | No Intervention | Control group, no stimulation of the phrenic nerve. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive electromagnetic stimulation | Device | Non-invasive bilateral electromagnetic stimulation of the phrenic nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of non-feasible stimulation, due to organisational or patient-specific reasons. | Percentage of non-feasible stimulation out of the total number of stimulations planned according to the investigation protocol. | 10 days |
| 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 (10 days) |
| Frequency of sufficient Tidal volume generated by electromagentical stimulation of the phrenic nerve (3-6 ml/kg ideal body weight) | Percentage of stimulated breaths above the cut-off Today volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths. Tidal volumes are measured by the mechanical ventilator. | Study duration (10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Variance of Tidal volume generated by electromagentical stimulation of the phrenic nerve | Measurement of variance among the Tidal volumes stimulated during the experimental therapy intervention; Tidal volumes are measured by the mechanical ventilator. | Study duration (10 days) |
| Correlation between amplitude and duration of sEMG signals during stimulated breathing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan J Schaller, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Univiversitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38403186 | Derived | Panelli A, Grimm AM, Krause S, Verfuss MA, Ulm B, Grunow JJ, Bartels HG, Carbon NM, Niederhauser T, Weber-Carstens S, Brochard L, Schaller SJ. Noninvasive Electromagnetic Phrenic Nerve Stimulation in Critically Ill Patients: A Feasibility Study. Chest. 2024 Sep;166(3):502-510. doi: 10.1016/j.chest.2024.02.035. Epub 2024 Feb 24. |
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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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15 patients in control group, 15 patients in interventional group with sequential design in term of daily frequency of non-invasive electromagnetic phrenic nerve stimulation, i.e. starting with 5 patients with 2 stimulation per day, followed by 5 patients with 3 stimulations and 5 patients with 5 stimulations per day
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sEMG amplitude and duration are measured by a device (sEMG Amplificator) connected to electrodes applied to the patient's chest during electromagnetic phrenic nerve stimulation. |
| Study duration (10 days) |
| Transpulmonary pressure during electromagnetical stimulation of the phrenic nerve | Transpulmonary pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | Study duration (10 days) |
| Occlusion pressure during electromagnetical stimulation of the phrenic nerve | Occlusion pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | Study duration (10 days) |
| Diaphragm thickening fraction | Diaphragm thickening fraction measured with ultrasound of the diaphragm. | approx. 28 days (till ICU discharge) |
| Diaphragm excursion | Diaphragm excursion measured with ultrasound of the diaphragm. | approx. 28 days (till ICU discharge) |
| Stimulated tracheal pressure during electromagentical stimulation of the phrenic nerve | Stimulated tracheal pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | Study duration (10 days) |
| Rapid Shallow Breathing Index (RSBI) record and evaluation. | Progression of RSBI during 10 days after subject inclusion, based on the mechanical ventilation parameters (Tidal volume) and the ICU continuous monitoring system (Respiratory Rate). | Study duration (10 days) |
| Lung compliance during electromagentical stimulation of the phrenic nerve | Lung compliance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | 10 days |
| Lung resistance during electromagentical stimulation of the phrenic nerve | Lung resistance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | 10 days |
| Maximal inspiratory pressure (MIP) during electromagnetical stimulation of the phrenic nerve. | MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | Study duration (10 days) |
| Expiratory and Inspiratory Diaphragm Thickness measured by Ultrasound | Diaphragm Thickness measured by Ultrasound as a baseline parameter for muscle atrophy. | Study duration (10 days) |
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
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