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NCT Number: NCT02411383

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

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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Key information

Conditions

Chronic Obstructive Airway Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Belgium

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuRx Diaphragm Pacing System

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.

Primary outcomes

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

    Time frame: 30 days

  2. Tolerability: Patient withdrawal from treatment.

    Time frame: 30 days

  3. Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.

    Time frame: 30 days

Secondary outcomes

  1. Composite endpoint

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Synapse Biomedical

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2015
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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