Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients

Muscle Weakness Clinical Trial

— STIMIT-I  

Official title:

Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946110
• Other study ID #: STIMIT-I
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: July 29, 2021

Study information

• Verified date: October 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• General Anaesthesia
• Muscle Weakness
• Paresis

Intervention

Device:
• Electromagnetic stimulation
Electromagnetic stimulation of the phrenic nerve

Locations

Country	Name	City	State
Germany	Charité - Univiversitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Stimit AG

Country where clinical trial is conducted

Germany, 

Outcome

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)