Patient/Ventilator Asynchrony Clinical Trial
Official title:
The Use of NAVA vs. Pressure Support During Asynchrony in Children
The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.
Asynchrony during assisted ventilation in children is common because of the presence of
uncuffed artificial airways and their rapid ventilatory rate with small volumes compared to
adults.As a result, the most common approach to ventilatory support in children is pressure
ventilation, since pressure targeted ventilation allows gas delivery to vary based on
patient demand. In addition, many manufacturers have incorporated adjuncts designed to
improve synchrony in pressure targeted ventilation. Most of today's ICU ventilators
incorporate rise time and control of the breath termination criteria in pressure ventilation
by either altering inspiratory time directly or adjusting the inspiratory flow termination
criteria in pressure support ventilation. In addition, careful adjustment of trigger
sensitivity, and insuring driving pressure is appropriately set to avoid large tidal volumes
improves synchrony in many patients. However, in spite of all of these potential adjustments
many pediatric patients are still asynchronous.
A recently released new mode of ventilation, NAVA (neurally adjusted ventilatory assist) is
designed to reduce the asynchrony that exists between the ventilator and the patient. With
NAVA, gas delivery from the mechanical ventilator is triggered, controlled and cycled by the
diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG
by the insertion of a specially designed nasogastric tube (NGT) with EMG electrodes that
cross the diaphragm. This NGT also functions similar to any standard NGT. NAVA is used to
control all aspects of assisted ventilatory support. A number of preliminary studies in
neonates and pediatric patients have demonstrated that patient ventilator synchrony is
improved with the application of NAVA. In general, tidal volumes delivered by the ventilator
are decreased, respiratory rates increased and peak inspiratory pressures decreased. In
these studies, triggering and cycling of the ventilator are controlled by the diaphragmatic
EMG in more than 70 % of the time. If the EMG signal does not activate or terminate positive
pressure backup flow/pressure/time signal, control gas delivery -as is customary in standard
modes of ventilatory support- takes over.
We hypothesize that the use of NAVA will improve trigger and flow synchrony in children and
insure that tidal volumes are normalized (6 to 8 ml/kg) in these patients.
Asynchrony will be studied in 12 mechanically ventilated pediatric patients in the Pediatric
ICU at Hospital Universitario Materno-Infantil La Paz in Madrid, Spain.
The study protocol has 5 phases
- Phase 0: patient asynchrony documentation and 10 min recording
- Phase 1: NAVA catheter insertion and 10 min recording in basal ventilatory mode after
20 min stabilization
- Phase 2: Pressure support is optimized and 10 min recording after 20 min stabilization
- Phase 3: NAVA mode ventilation and 10 min recording after 20 min stabilization
- Phase 4: Pressure support ventilation and 10 min recording after 20 min stabilization
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01049958 -
Study to Measure the Prevalence of Asynchrony In Mechanically Ventilated Patients
|
N/A |