Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity

Charite University, Berlin, Germany5 enrolled

Overview

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 in obese patients.

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 in obese patients

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

General Anaesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 18 years of age * American Society of Anaesthesiologists Classification I or II * Planned anesthesia with intubation * Adipositas Grade II-III 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. * 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