Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity (STIMIT-IA)
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About
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 in obese patients.
Full 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 in obese patients
Enrollment
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Inclusion criteria
- ≥ 18 years of age
- American Society of Anaesthesiologists Classification I or II
- Planned anesthesia with intubation
- Adipositas Grade II-III
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.
- 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
Trial design
Primary purpose
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Interventional model
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5 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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