Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity

Not Applicable

Completed

• Conditions: General Anaesthesia; Muscle Weakness
• Interventions: Device: Electromagnetic stimulation

• Registration Number: NCT05107167
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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 in obese patients.

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 in obese patients

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-04
• Study Start: 2021-12-14
• Status Verified: 2022-02
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electromagnetic stimulation	Electromagnetic stimulation	Electromagnetic stimulation of the phrenic nerve.

Primary Outcome Measures

Name	Time	Method
1.Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)	approximately 15 minutes	Mean tidal volume of 10 consecutively stimulations of the phrenic nerve

Secondary Outcome Measures

Name	Time	Method
Distance between anatomical landmarks and optimal stimulation locus	approximately 15 minutes	Distance between anatomical landmarks and optimal stimulation locus
Time to find the optimal stimulation point of the N. phrenicus	approximately 15 minutes	Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
Air pressure during each breath	approximately 15 minutes	Change in pressure in the duct from expiration to inspiration (mbar)
Feedback/Stimulation locus relation	approximately 15 minutes	When the stimulation locus is changed according to protocol the change of the triggered tidal volume is measured in % to the original location
Reproducibility of stimulation answer	approximately 15 minutes	Variation of stimulated tidal volumes and diaphragm contraction using mean and standard deviation of each stimulation intensity
Max inspiratory flow after stimulation	approximately 15 minutes	The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)
Diaphragmatic thickening fraction	approximately 15 minutes	Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
Latency between stimulation and feedback	approximately 15 minutes	Time between start and end of the stimulation in seconds
Incidence of Adverse Events during stimulation	approximately 15 minutes	Adverse Events elicited by the electromagnetic stimulation
Abdominal extension maximum	approximately 15 minutes	Extension of the abdomen in centimeter measured via abdominal belt
Intensity/Contractility relation	approximately 15 minutes	Correlation between the simulation intensity and the diaphragmatic contractility

Trial Locations

Locations (1)

Charité - Univiversitätsmedizin Berlin; 🇩🇪 Berlin, Germany