Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368485
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2006-08-22
Brief Title:
Neural Control of Non-invasive Ventilation in the Preterm
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Neural Control of Non-invasive Ventilation in the Preterm
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will use a new type of respirator in premature babies who need help with their breathing This new respirator uses signals from the babys diaphragm - the most important breathing muscle - to control the timing and the amount of air that the baby needs The goal of the study is to demonstrate that this new respirator can synchronize delivery of air to the babys efforts and that synchrony is maintained regardless of whether the baby is breathing with a tube or a mask
Detailed Description:
There is an abundance of evidence in the literature suggesting that maintenance of spontaneous breathing with a synchronized mode of ventilatory assist and the use of non-invasive interface to deliver the assist has the potential to significantly improve neonatal respiratory care Conventional modes of mechanical ventilation use pneumatic signals such as airway pressure flow or volume which are dampened by respiratory muscle weakness increased load impaired respiratory mechanics and leaks In order to improve patient ventilator synchrony further development over current technology is required
This study deals with the implementation and clinical evaluation of neural control of mechanical ventilation in the neonatal intensive care unit The goal is to demonstrate in pre-term newborns with extremely low birth weight that neural control of mechanical ventilation using the electrical activity of the diaphragm EAdi can synchronize delivery of assist to the patients inspiratory drive and that synchrony is maintained regardless of the interface used This proposal will introduce for the first time technology for neural triggering and cycling-off as well as neurally adjusted ventilatory assist NAVA in the treatment of pre-term infants
In Project 1 the aim is to demonstrate that neural triggering and cycling-off ie initiation and termination of ventilatory assist using EAdi improve infant-ventilator synchrony compared to conventional pneumatic trigger systems in pre-term infants with extremely low birth weight It is hypothesized that neural triggering and cycling-off of mechanical ventilation improves infant-ventilator synchrony This will be evaluated by comparing the infants neural timings inspiratory and expiratory to ventilator timings during conventional pressure support ventilation and during neural triggering and cycling-off We expect that patient-ventilator synchrony will be improved in the neural mode and that comfort will be lowest with increased asynchrony conventional modes and highest with improved infant-ventilator synchrony neural triggering and cycling-off
In Project 2 the aim is to demonstrate that administration of NAVA with invasive endotracheal intubation or non-invasive interface nasal prongs is equally efficient in terms of triggering and cycling-off The hypothesis is that with NAVA non-invasive ventilation with nasal prong is equally efficient as invasive ventilation In premature infants deemed ready for extubation NAVA will be implemented prior to and post-extubation with single nasal prong We anticipate that ventilatory assist will be delivered with full synchrony regardless of invasive or non-invasive delivery of assist and that there should be no difference in the delays between the onset of EAdi and ventilatory assist and in the delays between peak of EAdi and cycling-off We also expect that due to less airway resistance during non-invasive ventilation peak applied pressures and diaphragm activation levels will be lower
By improving patient-ventilator interaction and allowing use of a non-invasive patient-ventilator interface neural control of mechanical ventilators has the potential to significantly reduce ventilator-related complications reduce the incidence of lung injury facilitate weaning from mechanical ventilation and decrease the duration of stay in the intensive care unit and overall hospitalization These issues can be addressed in future randomized clinical trials in the case that the present short-term work has a positive outcome
This study deals with the implementation and clinical evaluation of neural control of mechanical ventilation in the neonatal intensive care unit The goal is to demonstrate in pre-term newborns with extremely low birth weight that neural control of mechanical ventilation using the electrical activity of the diaphragm EAdi can synchronize delivery of assist to the patients inspiratory drive and that synchrony is maintained regardless of the interface used This proposal will introduce for the first time technology for neural triggering and cycling-off as well as neurally adjusted ventilatory assist NAVA in the treatment of pre-term infants
In Project 1 the aim is to demonstrate that neural triggering and cycling-off ie initiation and termination of ventilatory assist using EAdi improve infant-ventilator synchrony compared to conventional pneumatic trigger systems in pre-term infants with extremely low birth weight It is hypothesized that neural triggering and cycling-off of mechanical ventilation improves infant-ventilator synchrony This will be evaluated by comparing the infants neural timings inspiratory and expiratory to ventilator timings during conventional pressure support ventilation and during neural triggering and cycling-off We expect that patient-ventilator synchrony will be improved in the neural mode and that comfort will be lowest with increased asynchrony conventional modes and highest with improved infant-ventilator synchrony neural triggering and cycling-off
In Project 2 the aim is to demonstrate that administration of NAVA with invasive endotracheal intubation or non-invasive interface nasal prongs is equally efficient in terms of triggering and cycling-off The hypothesis is that with NAVA non-invasive ventilation with nasal prong is equally efficient as invasive ventilation In premature infants deemed ready for extubation NAVA will be implemented prior to and post-extubation with single nasal prong We anticipate that ventilatory assist will be delivered with full synchrony regardless of invasive or non-invasive delivery of assist and that there should be no difference in the delays between the onset of EAdi and ventilatory assist and in the delays between peak of EAdi and cycling-off We also expect that due to less airway resistance during non-invasive ventilation peak applied pressures and diaphragm activation levels will be lower
By improving patient-ventilator interaction and allowing use of a non-invasive patient-ventilator interface neural control of mechanical ventilators has the potential to significantly reduce ventilator-related complications reduce the incidence of lung injury facilitate weaning from mechanical ventilation and decrease the duration of stay in the intensive care unit and overall hospitalization These issues can be addressed in future randomized clinical trials in the case that the present short-term work has a positive outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None