Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Chronic Obstructive Airway Disease

Intervention / Treatment
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* Device: NeuRx Diaphragm Pacing System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeuRx Diaphragm Pacing System (DPS)®<br>The NeuRx Diaphragm Pacing System (DPS)® is placed in the diaphragm during lung transplant. | Device: NeuRx Diaphragm Pacing System<br>* NeuRx Diaphragm Pacing System electrodes are placed in the diaphragm during lung transplant surgery. The diaphragm will be continually paced until the patient is free from the ventilator or the patient is discharged from the ICU whichever. Diaphragm measurements are taken daily to assess tolerability and pacing success.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Daily assessment of device or procedure-related adverse events until patient discharge. |  | 30 days | 
| Tolerability: Patient withdrawal from treatment. |  | 30 days | 
| Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint | Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragm pacing, Respiratory assistance, Lung transplant