STIMIT-I: Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Electromagnetic stimulation Electromagnetic stimulation of the phrenic nerve. |
Device: Electromagnetic stimulation
Electromagnetic stimulation of the phrenic nerve
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Tidal volume per breath [Study duration (approximately 10 minutes)]
Tidal volume
- 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.
- Latency between stimulation and feedback [Study duration (approximately 10 minutes)]
Time between start and end of the stimulation in seconds
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité - Univiversitätsmedizin Berlin | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Stimit AG
Investigators
- Principal Investigator: Stefan J Schaller, Prof. Dr., Charité - Universitätsmedizin Berlin, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STIMIT-I