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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

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.

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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)

Conditions

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Chronic Obstructive Airway Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NeuRx Diaphragm Pacing System (DPS)®

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

Group Type EXPERIMENTAL

NeuRx Diaphragm Pacing System

Intervention Type DEVICE

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.

Interventions

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NeuRx Diaphragm Pacing System

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.

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No