Preliminary evaluation of the specificity of the Parasternal Intercostal Muscle EMG signal and of the costal movement in detecting changes in the respiratory cycle and of the potential interfering effects of body movements
- Conditions
- R06Abnormalities of breathing
- Registration Number
- DRKS00020218
- Lead Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Brief Summary
A total of 16 subjects were recruited to this clinical investigation. 2/16 (12.5%) subjects of them were withdrawn (Subjects 005 and 013) Subjects were separated in two distinct groups. 10/16 (62.5%) were assessed according to the protocol described in Version 1.0 of the clinical investigation plan (Subjects 001-004 and 006-011). However, due to technical issues with subjects 008-011, the results of these subjects could not be used for analysis. The results of the remaining 6/16 (37,3 %) participants were evaluated according to Version 1.0 of the clinical investigation plan. The data discussed in the resulting interim analysis could not be used to determine whether PIM EMG and/or costal movement signals could be used as respiratory-phase-sensors. Based on the results of the first Interim report, the Clinical Investigation Plan was amended to Version 2.0. The subsequent testing protocol is not comparable with the original one. Unfortunately, the COVID-19 pandemic outbreak seriously delayed further recruitment in this study for Version 2.0 of the clinical investigation plan. Four subjects (012-014 and 016) were tested according to the amended protocol (Version 2.0). However, due to technical issues, the results for subject 013 could not be used for analysis. The assessment of the data showed that the EMG signal is in absolute an excellent and compared with the costal movement signal fa better indicator for the real-time inhalation phase detection. Medial electrode configuration was more accurate than the lateral one. Crosstalk issues had a negligible effect on maneuvers such as walking or neck rotation, while they relevantly biased maneuvers, such as push palms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 16
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Correlation between EMG recordings and Thermistor recordings<br><br>The study lasts at least 3 days. The maximum timeframe for all testing sessions together is 3 h and 10 min.<br>- 30 min for the screening (before the surgery)<br>- 10 min for the electrode placement (during the surgery)<br>- 1 h for the first testing session (2nd day after the surgery)<br>- 1 h 30 min for the second testing session) (3rd day after the surgery)
- Secondary Outcome Measures
Name Time Method - Videos of the sessions synchronized on the EMG and thermistor recording<br>- EMG analysis report<br>- Demographics<br>- Test session report