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

Not Applicable

Completed

• Conditions: Chronic Obstructive Airway Disease
• Interventions: Device: NeuRx Diaphragm Pacing System

• Registration Number: NCT02411383
• Lead Sponsor: Synapse Biomedical

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)

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuRx Diaphragm Pacing System (DPS)®	NeuRx Diaphragm Pacing System	The NeuRx Diaphragm Pacing System (DPS)® is placed in the diaphragm during lung transplant.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Composite endpoint	30 days	Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG).

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium