Current Environment:

Summary

Neurally adjusted ventilatory assist (NAVA) is an FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during inspiration, is measured. The ventilator triggers (synchronizes patient effort) and applies proportional assistance based on measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it. This mode of ventilation has been proven to be equivalent to pressure support ventilation (PSV). Theoretically, the breath-to-breath control offered by NAVA may not only trigger faster and synchronize better, but provide the support deemed appropriate by the central nervous center on demand. Traditionally in the intensive care unit (ICU), pressure support is applied to subject breathing spontaneously. Pressure is set to achieve a given tidal volume. The influence of changing lung compliance not only from the lung disease itself, but the interactions of the respiratory muscles can drastically change minute ventilation and contribute to hyper- or hypoventilation. These changes are typically found on assessment of end-tidal carbon dioxide (CO2), blood gas, or oxygen saturation (SpO2) monitoring; all of which are potentially preventable if we allowed the central nervous system to control the ventilator. NAVA may allow us to couple the central nervous system (neuro-coupling) with the ventilator to provide real-time proportional assistance, reduce work of breathing and apply physiologic breathing patterns.

Conditions

Respiratory Failure

Recruitment Status

Unknown status

Eligibility Criteria

Inclusion Criteria:

All intubated and mechanically ventilated patients in our intensive care units (ICUs) will be screened for the following inclusion criteria:

Age: 1 month to 18 years.
Mechanically ventilated for longer than 6 hours

Either:

Eligible for a spontaneous breathing mode of ventilation (not receiving chemical paralytics and has an appropriate spontaneous respiratory drive/rate given the size and condition of the patient) as determined by the team.

or

Currently in the pressure support ventilation (PSV) or neurally adjusted ventilatory assist (NAVA) mode of ventilation

Exclusion Criteria:

Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.
Uncuffed endotracheal tube (ETT)
Cervical-spine injury that prohibits rolling the patient for electrical impedance tomography (EIT) band placement.
Difficult airway
Congenital cyanotic heart defects
Positive end expiratory pressure (PEEP) > 15 cmH2O
Fractional inspired oxygen concentration (FIO2) > 0.8
Peak inspiratory pressure (PIP) > 30 cmH2O
Patients who are receiving chemical paralysis
History of prematurity (birth at post-conceptual age <37 weeks)

Intervention

Intervention Type

Intervention Name

Device

Neurally Adjusted Ventilatory Assist (NAVA)

Phase

Not Applicable

Gender

All

Min Age

1 Month

Max Age

18 Years

Download Date

March 21, 2019

Principal Investigator

John H Arnold

Primary Contact Information

Craig D Smallwood, BS RRT

craig.smallwood@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: