R06
Conditions
Interventions
Group 1: • Measurements of the EMGs of the parasternal intercostal muscles (PIM) with temporarily implantable electrodes at rest (lying, sitting, standing) and at specific movements of the thorax (mov
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 18 years - Scheduled for a thoracic surgery - Mental, anatomic and physiological conditions compatible with the participation in this clinical investigation - High motivation with realistic expectations regarding the participation in this clinical investigation - Signed and dated informed consent before the start of any study specific assessment
Exclusion criteria
Exclusion criteria: - Lack of compliance with any inclusion criteria - Pregnant or breast-feeding women - Other clinical diseases that might result in alteration of the outcomes of this clinical investigation - Use of an active implant - Known allergies or intolerance to the material used for this clinical investigation - Current participation in other drugs and/or medical device studies that can affect the results of the present clinical investigation - Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Correlation between EMG recordings and Thermistor recordings The study lasts at least 3 days. The maximum timeframe for all testing sessions together is 3 h and 10 min. - 30 min for the screening (before the surgery) - 10 min for the electrode placement (during the surgery) - 1 h for the first testing session (2nd day after the surgery) - 1 h 30 min for the second testing session) (3rd day after the surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Videos of the sessions synchronized on the EMG and thermistor recording - EMG analysis report - Demographics - Test session report | — |
Countries
Germany
Contacts
Public ContactGerhard Förster
SRH Wald-Klinikum Hals-Nasen-Ohrenheilkunde/Plastische Operationen
Outcome results
None listed