Skip to main content
Clinical Trials/NCT04884698
NCT04884698
Completed
Not Applicable

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

Stimit AG1 site in 1 country10 target enrollmentJune 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Stimit AG
Enrollment
10
Locations
1
Primary Endpoint
Change in airway pressure / endpoint Group 2:
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2021
End Date
December 13, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Stimit AG
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in airway pressure / endpoint Group 2:

Time Frame: During stimulation

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

Change in airway pressure / endpoint Group 1:

Time Frame: During stimulation

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

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

Time Frame: During stimulation

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)

Secondary Outcomes

  • Optimal stimulation site - distance(During stimulation)
  • Skin reactions / musle activation(During stimulation)
  • Safety outcome(During stimulation and postoperatively, usually within 2-3 hours)
  • Tidal volumes(During stimulation)
  • Diaphragmatic contraction(During stimulation)
  • Feedback signals(During stimulation)
  • Time stimulation start to end(During stimulation)
  • Optimal stimulation site - time(During stimulation)
  • Correlation stimulation intensity and diaphragm contraction(During stimulation)

Study Sites (1)

Loading locations...

Similar Trials