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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Airway Disease
- Sponsor
- Synapse Biomedical
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Tolerability: Patient withdrawal from treatment.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is undergoing bilateral lung transplantation
- •Signed written informed consent has been obtained prior to any study related procedure
Exclusion Criteria
- •Diaphragm malformation which makes the electrode insertion impossible
- •Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
- •Participation in other clinical studies that could interfere with the results in the ongoing study
Outcomes
Primary Outcomes
Tolerability: Patient withdrawal from treatment.
Time Frame: 30 days
Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
Time Frame: 30 days
Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.
Time Frame: 30 days
Secondary Outcomes
- Composite endpoint(30 days)