Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients (STIMIT-I)

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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; General Anaesthesia
• Intervention / Treatment: Device: Electromagnetic stimulation

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Univiversitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electromagnetic stimulation; Electromagnetic stimulation of the phrenic nerve.	Device: Electromagnetic stimulation; Electromagnetic stimulation of the phrenic nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume per breath	Tidal volume	Study duration (approximately 10 minutes)
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)
Abdominal extension maximum	Extension of the abdomen measured via in abdominal belt	Study duration (approximately 10 minutes)
Air pressure during each breath	Change in pressure in the duct from expiration to inspiration (mbar)	Study duration (approximately 10 minutes)
Diaphragmatic thickening fraction	Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation	Study duration (approximately 10 minutes)
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)
Latency between stimulation and feedback	Time between start and end of the stimulation in seconds	Study duration (approximately 10 minutes)
Intensity/Contractility relation	Correlation between the simulation intensity and the diaphragmatic contractility	Study duration (approximately 10 minutes)
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)
Distance between anatomical landmarks and optimal stimulation locus	Distance between anatomical landmarks and optimal stimulation locus	Study duration (approximately 10 minutes)
Reproducibility of stimulation answer	Variation of stimulated tidal volumes and diaphragm contraction	Study duration (approximately 10 minutes)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Adverse Events elicited by the electromagnetic stimulation	Study duration (approximately 10 minutes)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Stimit AG
• Investigators: Principal Investigator: Stefan J Schaller, Prof. Dr., Charité - Universitätsmedizin Berlin, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: muscle weakness; VIDD; ICUAW
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Paresis
• Other Study ID Numbers: STIMIT-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data can be requested on reasonable scientific request.
• IPD Sharing Time Frame: After publication of scientific manuscript.
• IPD Sharing Access Criteria: Deidentified data can be requested on reasonable scientific request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No