This project aims to answer whether the use of a Neurally-Adjusted Ventilatory Assistance mode for non-invasive ventilation in pediatric patients with bronchiolitis results in improved comfort and reduced escalations in therapy (including intubation) when compared to using a standard mode of non-invasive ventilation. Neurally-Adjusted Ventilatory Assistance (NAVA) has been shown to result in greater synchrony then the standard mode of non-invasive ventilation. The study team hypothesizes that this improved synchrony can result in important clinical improvements when NAVA is used to treat children with bronchiolitis.
Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU
Patient's provider believes there is equipoise between the use of NAVA or conventional non-invasive ventilation for the patient
Patients unable to utilize a nasogastric tube
Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure
Patients with hypotonia
Patients likely to require imminent intubation: >0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) > 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality)
Parallel
Standard Non-Invasive Mechanical Servo Ventilation
DeviceThe active comparator arm will utilize a standard non-invasive mode to provide ventilation support
Neurally-Adjusted Ventilatory Assistance (NAVA) Non-Invasive Mechanical Servo Ventilation
DeviceThe experimental arm will utilize a NAVA mode to provide non-invasive ventilation support
Baseline Respiratory Severity Score (RSS)
RSS is a validated measure of severity in children with bronchiolitis, scored from 0-12 with higher numbers indicating greater severity. If able, baseline scores will be taken before randomization to either treatment arm.
Average Respiratory Severity Score (RSS)
RSS is a validated measure of severity in children with bronchiolitis, scored from 0-12 with higher numbers indicating greater severity. Average RSS values over a 48-hour period will be reported for each treatment arm.
Baseline Electrical Activity of the Diaphragm (Edi)
Measure, in microvolts, recorded by the Edi catheter to reflect activity of diaphragmatic activation. Higher values correspond with increased diaphragmatic activation. If able, will be collected prior to randomization to either treatment arm.
Average Baseline Electrical Activity of the Diaphragm (Edi)
Measure, in microvolts, recorded by the Edi catheter to reflect activity of diaphragmatic activation. Higher values correspond with increased diaphragmatic activation. Average Edi values over a 48-hour period will be reported for each treatment arm.
Duration of Non-Invasive Ventilation
The duration, in hours, that a patient requires non-invasive ventilation.
Number of participants requiring intubation
If a patient requires intubation due to bronchiolitis, this information will be recorded
Frequency of increasing ventilatory support
The number of times that a physician increases respiratory support settings on the ventilator (other than FiO2) while remaining within protocol parameters will be documented. The number of events, limited to one event per hour, of increase in respiratory support will be counted during the study period. A greater number of increases in ventilatory support will indicate inadequate response to the treatment arm intervention.
Number of patients requiring dexmedetomidine
The number of patients requiring dexmedetomidine will be tabulated. The use of dexmedetomidine use likely reflects patient agitation and inability to ventilate adequately on non-invasive ventilation. The use of dexmedetomidine may indicate more agitation present within a given treatment arm.
Click on the lead sponsor to view all of their trials.
