Chronic Obstructive Airway Disease Clinical Trial
Official title:
Prospective, Single-centre, Open-label Clinical Study to Investigate the Safety and Performance of the NeuRx Diaphragm Pacing System (DPS) in Patients Undergoing Bilateral Lung Transplantation
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.
This study is a prospective, single-center feasibility study to acquire more knowledge
regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with
this system during the weaning period from mechanical ventilation in the Intensive Care Unit
in patients after bilateral lung transplant. The objectives are to evaluate the safety and
technical performance of DPS by assessing:
- the immediate safety and technical surgical results of implantation
- the safety and tolerability of use and removal until patient discharge from the
Intensive Care Unit (ICU) or hospital
- the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance,
and diaphragm electromyography (EMG)
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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