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

NCT01504373 | Completed DMC

• 1 other identifier: 10070341
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

NAVA; neurally adjusted ventilatory support; lung injury; ventilation; lung volume distribution; oxygen cost of breathing

Outcome Measures

Primary Outcomes (2)

• Regional distribution difference measured by electrical impedence tomography (EIT)

  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.

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

• Oxygen and metabolic cost of breathing

  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.

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

Secondary Outcomes (2)

• Oxygenation

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

• Lung mechanics

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

Study Arms (2)

NAVA-PSV

Subject will receive 4 hours of NAVA followed by 4 hours of PSV.

Device: Neurally Adjusted Ventilatory Assist (NAVA)

PSV-NAVA

Subject will receive 4 hours of PSV followed by 4 hours of NAVA.

Device: Neurally Adjusted Ventilatory Assist (NAVA)

Interventions

Neurally Adjusted Ventilatory Assist (NAVA) DEVICE

Subjects will be placed in the NAVA mode of ventilation.

NAVA-PSV; PSV-NAVA

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Lung Injury; Respiratory Aspiration

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• John Arnold, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate, Critical Care Medicine

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: January 5, 2012
• Study Start: May 1, 2011
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

US (1)