Status:
COMPLETED
"Electromagnetical Stimulation of Phrenic Nerve to Generate Contraction of the Diaphragm"
Lead Sponsor:
Stimit AG
Conditions:
Healthy Subjects
Elective Surgical Procedure
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
- Applicable for group 2 (intubated and mechanically ventilated) patients: Exclusion criteria at the time of stimulation:
- Unstable patient after induction of anesthesia and intubation
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04884698
Start Date
June 25 2021
End Date
December 13 2021
Last Update
January 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Swiss Paraplegic centre
Nottwil, Switzerland