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Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients

NCT ID: NCT04946110

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2021-07-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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General Anaesthesia Muscle Weakness

Keywords

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VIDD ICUAW muscle weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Electromagnetic stimulation

Electromagnetic stimulation of the phrenic nerve.

Group Type EXPERIMENTAL

Electromagnetic stimulation

Intervention Type DEVICE

Electromagnetic stimulation of the phrenic nerve

Interventions

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Electromagnetic stimulation

Electromagnetic stimulation of the phrenic nerve

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stimit AG

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Stefan J Schaller

Deputy Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J Schaller, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité - Universitätsmedizin Berlin, Berlin, Germany

Locations

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Charité - Univiversitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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STIMIT-I

Identifier Type: -

Identifier Source: org_study_id