Clinical trial NCT01504373: Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation
Official title: Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: NAVA
neurally adjusted ventilatory support
lung injury
ventilation
lung volume distribution
oxygen cost of breathing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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

     1. 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
     2. Currently in the pressure support ventilation (PSV) or neurally adjusted ventilatory assist (NAVA) mode of ventilation

Exclusion Criteria:

1. 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.
2. Uncuffed endotracheal tube (ETT)
3. Cervical-spine injury that prohibits rolling the patient for electrical impedance tomography (EIT) band placement.
4. Difficult airway
5. Congenital cyanotic heart defects
6. Positive end expiratory pressure (PEEP) \> 15 cmH2O
7. Fractional inspired oxygen concentration (FIO2) \> 0.8
8. Peak inspiratory pressure (PIP) \> 30 cmH2O
9. Patients who are receiving chemical paralysis
10. History of prematurity (birth at post-conceptual age \<37 weeks)

Primary outcomes:
measure: Regional distribution difference measured by electrical impedence tomography (EIT)
timeFrame: Change from baseline regional distribution of ventilation after the 4th hour and after 8th hour
measure: Oxygen and metabolic cost of breathing
timeFrame: Change from baseline oxygen cost of breathing and carbon dioxide production after the 4th hour and after the 8th hour
Secondary outcomes:
measure: Oxygenation
timeFrame: Monitored/recorded continuously for duration of study (8 hours total)
measure: Lung mechanics
timeFrame: Monitored/recorded every 30 seconds for duration of study (8 hours total)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: