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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
5
Electromagnetic stimulation of the phrenic nerve
Charité - Univiversitätsmedizin Berlin
Berlin, Germany
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
Time frame: Study duration (approximately 10 minutes)
Tidal volume per breath
Tidal volume
Time frame: 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)
Time frame: Study duration (approximately 10 minutes)
Abdominal extension maximum
Extension of the abdomen measured via in abdominal belt
Time frame: Study duration (approximately 10 minutes)
Air pressure during each breath
Change in pressure in the duct from expiration to inspiration (mbar)
Time frame: Study duration (approximately 10 minutes)
Diaphragmatic thickening fraction
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
Time frame: 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.
Time frame: Study duration (approximately 10 minutes)
Latency between stimulation and feedback
Time between start and end of the stimulation in seconds
Time frame: Study duration (approximately 10 minutes)
Intensity/Contractility relation
Correlation between the simulation intensity and the diaphragmatic contractility
Time frame: 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
Time frame: Study duration (approximately 10 minutes)
Distance between anatomical landmarks and optimal stimulation locus
Distance between anatomical landmarks and optimal stimulation locus
Time frame: Study duration (approximately 10 minutes)
Reproducibility of stimulation answer
Variation of stimulated tidal volumes and diaphragm contraction
Time frame: Study duration (approximately 10 minutes)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events elicited by the electromagnetic stimulation
Time frame: Study duration (approximately 10 minutes)
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