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

Synapse Biomedical4 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Airway Disease

Interventions

NeuRx Diaphragm Pacing SystemDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Safety: Daily assessment of device or procedure-related adverse events until patient discharge.

Time frame: 30 days

Tolerability: Patient withdrawal from treatment.

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

Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG).

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.