General Anaesthesia, Muscle Weakness
Conditions
Keywords
VIDD, ICUAW, muscle weakness
Brief 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. 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.
Interventions
Electromagnetic stimulation of the phrenic nerve
Sponsors
Stimit AG
Charite University, Berlin, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age * American Society of Anaesthesiologists Classification I or II
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) | Study duration (approximately 10 minutes) | Mean tidal volume of 10 consecutively stimulations of the phrenic nerve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Max inspiratory flow after stimulation | Study duration (approximately 10 minutes) | The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second) |
| Abdominal extension maximum | Study duration (approximately 10 minutes) | Extension of the abdomen measured via in abdominal belt |
| Air pressure during each breath | Study duration (approximately 10 minutes) | Change in pressure in the duct from expiration to inspiration (mbar) |
| Diaphragmatic thickening fraction | Study duration (approximately 10 minutes) | Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation |
| Feedback/Stimulation locus relation | Study duration (approximately 10 minutes) | When the stimulation locus is changed according to protocol the change of the triggered breath is measured in % to the original location. |
| Tidal volume per breath | Study duration (approximately 10 minutes) | Tidal volume |
| Intensity/Contractility relation | Study duration (approximately 10 minutes) | Correlation between the simulation intensity and the diaphragmatic contractility |
| Time to find the optimal stimulation point of the N. phrenicus | Study duration (approximately 10 minutes) | Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds |
| Distance between anatomical landmarks and optimal stimulation locus | Study duration (approximately 10 minutes) | Distance between anatomical landmarks and optimal stimulation locus |
| Reproducibility of stimulation answer | Study duration (approximately 10 minutes) | Variation of stimulated tidal volumes and diaphragm contraction |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Study duration (approximately 10 minutes) | Adverse Events elicited by the electromagnetic stimulation |
| Latency between stimulation and feedback | Study duration (approximately 10 minutes) | Time between start and end of the stimulation in seconds |
Countries
Germany
Outcome results
None listed