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NCT Number: NCT01504373

Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation

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.

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Key information

Conditions

Respiratory Failure Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neurally Adjusted Ventilatory Assist (NAVA)

Device

Subjects will be placed in the NAVA mode of ventilation.

Primary outcomes

  1. Regional distribution difference measured by electrical impedence tomography (EIT)

    Time frame: Change from baseline regional distribution of ventilation after the 4th hour and after 8th hour

    Regional distribution difference measured by EIT. Area and upper to lower lung volume ratios (as determined with EIT) will be the primary data analyzed. Global and regional filling of the lung will be compared during pressure support ventilation and neurally adjusted ventilatory assist.

  2. Oxygen and metabolic cost of breathing

    Time frame: Change from baseline oxygen cost of breathing and carbon dioxide production after the 4th hour and after the 8th hour

    Oxygen consumption (VO2), carbon dioxide production (VCO2), respiratory quotient (RQ), and Work of breathing (VO2/time) will be measured and compared between baseline, pressure support ventilation (PSV), and neurally adjusted ventilatory assist (NAVA) within each patient. Percent change will be compared between control (PSV) and NAVA group.

Secondary outcomes

  1. Oxygenation

    Time frame: Monitored/recorded continuously for duration of study (8 hours total)

    Oxygen saturation measured by pulse oxymetry (SpO2), SpO2/FiO2 ratio, non-invasive oxygen content (SpOC), and frequency of desaturations will be recorded continuously and compared between pressure support ventilation (PSV) and neurally adjusted ventilatory assist (NAVA). Although not a primary outcome measure of this study, oxygenation will allow us to further determine the safety of NAVA compared to PSV.

  2. Lung mechanics

    Time frame: Monitored/recorded every 30 seconds for duration of study (8 hours total)

    Compliance, peak inspiratory pressures, positive end expiratory pressure, tidal volumes, inspired oxygen concentration, electrical activity of the diaphragm (Edi), specific Edi (ratio of tidal volume to Edi), will be measured in each patient during pressure support ventilation and neurally adjusted ventilatory assist.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2012
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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