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

NCT04884698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-01-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Stimit AG

    lead INDUSTRY

Principal Investigators

  • Michael Baumberger, MD · Swiss Paraplegic Center Nottwil

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2021-12-13
Completion
2021-12-13

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884698 on ClinicalTrials.gov