Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients

NCT04946110 | Completed

• 1 other identifier: STIMIT-I
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anaesthesia; Muscle Weakness

Keywords

VIDD; ICUAW; muscle weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Tidal volume per breath

  Study duration (approximately 10 minutes)

• Max inspiratory flow after stimulation

  Study duration (approximately 10 minutes)

• Abdominal extension maximum

  Study duration (approximately 10 minutes)

• Air pressure during each breath

  Study duration (approximately 10 minutes)

• Diaphragmatic thickening fraction

  Study duration (approximately 10 minutes)

Study Arms (1)

Electromagnetic stimulation

EXPERIMENTAL

Electromagnetic stimulation of the phrenic nerve.

Device: Electromagnetic stimulation

Interventions

Electromagnetic stimulation DEVICE

Electromagnetic stimulation of the phrenic nerve

Electromagnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• American Society of Anaesthesiologists Classification I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Stimit AG: collaborator

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Stefan J Schaller, Prof. Dr.

  Charité - Universitätsmedizin Berlin, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Director

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: June 30, 2021
• Study Start: July 13, 2021
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of scientific manuscript.
• Access Criteria: Deidentified data can be requested on reasonable scientific request.

Locations

DE (1)