Chronic Obstructive Airway Disease
Conditions
Keywords
Diaphragm pacing, Respiratory assistance, Lung transplant
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)
Interventions
DEVICENeuRx 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.
Sponsors
Synapse Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint | 30 days | Effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG). |
Countries
Belgium
Outcome results
None listed