Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in the Intensive Care Unit (ICU).
This is a prospective, open-label, single-center study to examine the feasibility of the TransLoc DPS electrode placement and removal. Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes) and will be followed until electrode removal up to seven days post-procedure. Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
University Hospital
Cleveland, Ohio, United States
Number of Participant That Experience Adverse Procedure and/or Device Effects
All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Time frame: Implantation through hospital discharge or Day 7, whichever comes first.
Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume.
Time frame: Postoperatively on Day 1
Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
Time frame: Postoperatively Day 1
Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Postop Day 1 through hospital discharge or 7 days, whichever comes first
Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Comparison of Percentage of Predicted Tidal Volumes Measured.
Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm.
Time frame: Postop Day 1
Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
Number of participants in which stimulation successfully achieves acceptable tidal volumes of at least 6cc/kg of predicted body weight (PBW). This predicted tidal volume measurement is based on the NIH NHLBI ARDS Clinical Network (ARDSnet) MV protocol criteria for Acute Respiratory Lung Syndrome (ARDS) protection resulting from the ALVELOI study.
Time frame: Postop Day 1
Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first