NCT04176744

Optimization of Non-invasive Diaphragm Activation Using Magnetic Phrenic Nerve Stimulation

Completed NA Last updated 12 August 2020

What this trial tests

NA trial testing Uni- and bilateral magnetic phrenic nerve stimulation in Healthy in 17 participants. Completed in 15 July 2020.

Timeline

9 December 2019

Primary endpoint
15 July 2020

15 July 2020

Quick facts

Lead sponsor	Swiss Federal Institute of Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	17
Start date	9 December 2019
Primary completion	15 July 2020
Estimated completion	15 July 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• Uni- and bilateral magnetic phrenic nerve stimulation

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Swiss Federal Institute of Technology

Who can join

Adults 18 to 35, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of mechanical ventilation (MV) to replace spontaneous breathing has been associated with respiratory muscle dysfunction and lung injury from positive pressure. While using MV in an intensive care unit setting, the diaphragm is unloaded, potentially resulting in early development of diaphragmatic atrophy in as early as 18 hours of complete diaphragm inactivity. These changes in muscle properties result in a decrease in the force generating capability of the muscle, ultimately resulting in difficulty to restore spontaneous breathing and a subsequent prolonged weaning process or failure. A prolonged weaning period is associated with longer duration of MV, which may result in a cascade of further diaphragm dysfunction, weakness, and injury.

Stimulation of the phrenic nerves to produce diaphragm contraction and activity is a possible mechanism to reduce MV related diaphragm dysfunction. Two promising studies have shown the potential of repetitive phrenic nerve stimulation on inducing diaphragm activity in human subjects with trains of pulses via both cervical and bilateral phrenic nerve stimulation. However, neither study provided optimal stimulation settings. As such, the primary purpose of this study is to investigate the optimal settings for noninvasive phrenic nerve stimulation to induce diaphragm contraction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Inspiratory response and side-effects to rapid bilateral magnetic phrenic nerve stimulation using differently shaped coils: implications for stimulation-assisted mechanical ventilation.
   Boyle KGPJM, Eichenberger PA, Schön P, Spengler CM. · · 2022 · cited 7× · PMID 36528761 · DOI 10.1186/s12931-022-02251-y