Muscle Weakness Clinical Trial
— STIMIT-IOfficial title:
Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
NCT number | NCT04946110 |
Other study ID # | STIMIT-I |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 13, 2021 |
Est. completion date | July 29, 2021 |
Verified date | October 2021 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | July 29, 2021 |
Est. primary completion date | July 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Univiversitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Stimit AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) | Mean tidal volume of 10 consecutively stimulations of the phrenic nerve | Study duration (approximately 10 minutes) | |
Secondary | Tidal volume per breath | Tidal volume | Study duration (approximately 10 minutes) | |
Secondary | Max inspiratory flow after stimulation | The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second) | Study duration (approximately 10 minutes) | |
Secondary | Abdominal extension maximum | Extension of the abdomen measured via in abdominal belt | Study duration (approximately 10 minutes) | |
Secondary | Air pressure during each breath | Change in pressure in the duct from expiration to inspiration (mbar) | Study duration (approximately 10 minutes) | |
Secondary | Diaphragmatic thickening fraction | Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation | Study duration (approximately 10 minutes) | |
Secondary | 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. | Study duration (approximately 10 minutes) | |
Secondary | Latency between stimulation and feedback | Time between start and end of the stimulation in seconds | Study duration (approximately 10 minutes) | |
Secondary | Intensity/Contractility relation | Correlation between the simulation intensity and the diaphragmatic contractility | Study duration (approximately 10 minutes) | |
Secondary | 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 | Study duration (approximately 10 minutes) | |
Secondary | Distance between anatomical landmarks and optimal stimulation locus | Distance between anatomical landmarks and optimal stimulation locus | Study duration (approximately 10 minutes) | |
Secondary | Reproducibility of stimulation answer | Variation of stimulated tidal volumes and diaphragm contraction | Study duration (approximately 10 minutes) | |
Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse Events elicited by the electromagnetic stimulation | Study duration (approximately 10 minutes) |
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