Pediatric Acute Respiratory Failure Clinical Trial
Official title:
A Multicentre, Randomized, Clinical Trial of Noninvasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure - NINAVAPed Protocol
It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to pressure support to provide noninvasive ventilation to children will result in a decrease in the number of children with moderate to severe respiratory failure failing noninvasive ventilation and requiring endotracheal intubation. It is further hypothesized that noninvasive ventilation with NAVA compared to pressure support will result in a decrease in the length of mechanical ventilation, and the length of PICU and hospital stay.
Mechanical ventilation (MV) refers to the use of life-support technology to perform the work
of breathing for patients who are unable to breathe on their own. One of the most common
reasons for a Pediatric Intensive Care Unit (PICU) admission is the need for mechanical
ventilation. However, MV is associated with increased morbidity (endotracheal intubation,
tracheal edema, atelectasis, cardiovascular instability, ventilator-associated pneumonia,
bleeding, pneumothorax, chronic lung disease, etc), a long length of stay in the PICU and
high health care costs. Noninvasive ventilation (NIV) has become a primary approach to
ventilatory support of patients of all ages and it is estimated that it can avoid
endotracheal intubation and replace conventional mechanical ventilation in around 60% of
patients with acute respiratory failure. NIV has been shown to ameliorate clinical signs of
failure and improve gas exchange while reducing the need for endotracheal intubation (ETI)
thus avoiding the risks associated with invasive ventilation. NIV has been shown to decrease
the length of mechanical ventilation, the risk of ventilator associated pneumonia, the
sedation requirement, the length of ICU and hospital stay and mortality, while improving the
ability to tolerate enteral feeds. NIV does not increase beside caregiver time and does
decrease cost.
With children because of the difficulty in assuring the patient's cooperation, the lack of
available high quality masks and the resulting size of the air leak, synchrony between the
ventilatory pattern of the patient and the support provided by the ventilator is poor. This
problem had lead to repeated failure of noninvasive ventilation in children. The primary
mode of noninvasive ventilatory support is pressure support (NIV PS). This mode is triggered
to inspiration and cycled to exhalation by changes in patient inspiratory gas flow. But with
air leaks the ability of the ventilator to coordinate with the patient is decreased.
A new mode of ventilation, Neurally Adjusted Ventilatory Assist (NAVA) has been recently
introduced. This mode triggers, cycles and regulates gas delivery based on the diaphragmatic
EMG signal via a specially designed nasogastric tube (Edi). As a result, air leaks do not
affect the ability of the ventilator to synchronize gas delivery with the patient increasing
patient ventilator synchrony. Based on the operation of NAVA it is expected to increase the
successful application of noninvasive ventilation to children.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care