NCT04884698

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

"Electromagnetical Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Healthy Subjects and Anaesthetized and Intubated Patients - a Feasibility Study"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Stimit AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Stimit Activator	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

Timeline

• Start date: 2021-06-25
• Primary completion: 2021-12-13
• Completion: 2021-12-13
• First posted: 2021-05-13
• Last updated: 2022-01-06

Locations

1 site across 1 country: Switzerland