Trials / Completed
CompletedNCT02411383
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Synapse Biomedical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2015-04-08
- Last updated
- 2016-04-13
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02411383. Inclusion in this directory is not an endorsement.