"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"

NCT04884698 | Completed

• 1 other identifier: Stimit swiss I
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The scientific study is intended to show that external non-invasive electromagnetic stimulation can be used to safely and effectively stimulate the phrenic nerve in awake healthy subjects as well as in ventilated, anesthetized patients and that the stimulation can generate a diaphragmatic contraction that generates significant breath volume - a Controlled Own Breath (COB). Also of interest is the reproducibility of the generated diaphragmatic movements and the reliability of different feedback signals for detecting the generated diaphragmatic contraction. This applies to inspiration and expiration detection for subsequent synchronization mechanisms of the magnetic stimulator for patient-initiated breathing as well as to contraction intensity. Further, the characterization of the position finding process is of great importance, so that technical developments can further simplify the process of coil positioning in the future. The possible occurrence of discomfort and pain sensation will also be investigated in awake healthy volunteers. Different stimulation protocols will be used. Finally, it will be investigated whether an adjusted coil position still triggers reproducible diaphragmatic contractions after removal and repositioning in the same configuration. The knowledge gained will be used to further develop the technique and to prepare a study in critically ill, ventilated patients where the diaphragmatic muscle is to be treated preventively by stimulating the phrenic nerve, in order to prevent atrophy of the muscle.

Conditions

Healthy Subjects; Elective Surgical Procedure

Outcome Measures

Primary Outcomes (3)

• Change in airway pressure / endpoint Group 1:

  The primary outcome / endpoint is the change in airway pressure at the mouth during stimulation as seen with or without the use of the ventilator

  During stimulation

• Discomfort / pain during stimulation measured by Visual Analogue Scale / endpoint Group 1:

  The primary outcome / endpoint is the level of discomfort / pain during stimulation, measured by Visual Analogue Scale(0-100, with 100 being worst pain / discomfort)

  During stimulation

• Change in airway pressure / endpoint Group 2:

  The primary outcome / endpoint is the change in airway pressure during stimulation as seen with or without the use of the ventilator during stimulation.

  During stimulation

Secondary Outcomes (9)

• Diaphragmatic contraction

  During stimulation

• Feedback signals

  During stimulation

• Time stimulation start to end

  During stimulation

• Correlation stimulation intensity and diaphragm contraction

  During stimulation

• Optimal stimulation site - distance

  During stimulation

Study Arms (1)

Phrenic nerve stimulation with Stimit Activator

EXPERIMENTAL

Device: Stimit Activator

Interventions

Stimit Activator DEVICE

The Stimit Activator Device is composed of three components. 1. A magnetic stimulator generating current pulses 2. A novel Stimit coil design optimized for phrenic nerve stimulation 3. A coil positioning device for quick, easy and reproducible coil positioning

Phrenic nerve stimulation with Stimit Activator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons aged \> 18 years
• Applicable for Group 2: planned for elective surgery
• No relevant pre-existing conditions - corresponding to American Society of Anesthesiologists (ASA) level of I-II.
• Written informed consent by the patient for participation in the study given

You may not qualify if:

• chronic lung diseases (bronchial asthma, COPD)
• known diaphragmatic weakness
• known neurological conditions with motor muscle weakness
• known paralysis of the phrenic nerve
• conditions that limit the mobility of the diaphragm (high intra-abdominal pressure, ascites, BMI \>30)
• not able to read and understand the national language German
• skin lesions, infections or strictures in the neck area
• persons with Implanted cardiac support systems (pacemaker, implanted defibrillator)
• persons with implanted medical pumps
• pregnant women
• persons deprived of liberty by administrative or judicial decision or under legal guardianship.
• Participation in another clinical trial
• Unstable patient after induction of anesthesia and intubation

Sponsors & Collaborators

• Stimit AG: lead

Study Sites (1)

Swiss Paraplegic centre

Nottwil, Switzerland

Location

Study Officials

• Michael Baumberger, MD

  Swiss Paraplegic Center Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, sponsor-initiated feasibility study. 2 groups of patients treated - healthy subjects and elective surgery patient

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 13, 2021
• Study Start: June 25, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: January 6, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)