Neural Control of Non-invasive Ventilation in the Preterm
Condition: Respiratory Distress Syndrome, Newborn; Infant, Premature
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional
Phase: Phase 1

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 baby's 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 baby's 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 patient's 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 (i.e.
      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 infant's 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.
    

Intervention name(s): Neurally Controlled Mechanical Ventilation
Intervention type(s): Device
Intervention description(s): A new mode of mechanical ventilation controlled by the electrical activity of the diaphragm (NAVA) will be used before and after extubation.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diaphragm electrical activity; non invasive ventilation; patient ventilator interaction