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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10
Non-invasive bilateral electromagnetic stimulation of the phrenic nerve
Charité - Univiversitätsmedizin Berlin
Berlin, Germany
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.
Time frame: 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
Time frame: 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.
Time frame: Study duration (10 days)
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.
Time frame: Study duration (10 days)
Correlation between amplitude and duration of sEMG signals during stimulated breathing.
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.
Time frame: 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.
Time frame: 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.
Time frame: Study duration (10 days)
Diaphragm thickening fraction
Diaphragm thickening fraction measured with ultrasound of the diaphragm.
Time frame: approx. 28 days (till ICU discharge)
Diaphragm excursion
Diaphragm excursion measured with ultrasound of the diaphragm.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 10 days
Lung resistance during electromagentical stimulation of the phrenic nerve
Lung resistance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Time frame: 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.
Time frame: Study duration (10 days)
Expiratory and Inspiratory Diaphragm Thickness measured by Ultrasound
Diaphragm Thickness measured by Ultrasound as a baseline parameter for muscle atrophy.
Time frame: Study duration (10 days)
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