Charité - Univiversitätsmedizin Berlin
Berlin, 10117, Germany
NCT Number: NCT04946110
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Berlin, 10117, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electromagnetic stimulation of the phrenic nerve
Time frame: Study duration (approximately 10 minutes)
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
Time frame: Study duration (approximately 10 minutes)
Tidal volume
Time frame: Study duration (approximately 10 minutes)
The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)
Time frame: Study duration (approximately 10 minutes)
Extension of the abdomen measured via in abdominal belt
Time frame: Study duration (approximately 10 minutes)
Change in pressure in the duct from expiration to inspiration (mbar)
Time frame: Study duration (approximately 10 minutes)
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
Time frame: 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.
Time frame: Study duration (approximately 10 minutes)
Time between start and end of the stimulation in seconds
Time frame: Study duration (approximately 10 minutes)
Correlation between the simulation intensity and the diaphragmatic contractility
Time frame: Study duration (approximately 10 minutes)
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
Time frame: Study duration (approximately 10 minutes)
Variation of stimulated tidal volumes and diaphragm contraction
Time frame: Study duration (approximately 10 minutes)
Adverse Events elicited by the electromagnetic stimulation
Charite University, Berlin, Germany
Other
Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
Acronym: STIMIT-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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