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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01504373
First received: November 4, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Respiratory Failure
Device: Neurally Adjusted Ventilatory Assist (NAVA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Oxygenation [ Time Frame: Monitored/recorded continuously for duration of study (8 hours total) ] [ Designated as safety issue: Yes ]
    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.

  • Lung mechanics [ Time Frame: Monitored/recorded every 30 seconds for duration of study (8 hours total) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 25
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NAVA-PSV
Subject will receive 4 hours of NAVA followed by 4 hours of PSV.
Device: Neurally Adjusted Ventilatory Assist (NAVA)
Subjects will be placed in the NAVA mode of ventilation.
PSV-NAVA
Subject will receive 4 hours of PSV followed by 4 hours of NAVA.
Device: Neurally Adjusted Ventilatory Assist (NAVA)
Subjects will be placed in the NAVA mode of ventilation.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504373

Contacts
Contact: Craig D Smallwood, BS RRT craig.smallwood@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Craig D Smallwood, BS RRT       craig.smallwood@childrens.harvard.edu   
Sub-Investigator: Gerhard Wolf, MD         
Sub-Investigator: Craig Smallwood, RRT         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: John Arnold, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01504373     History of Changes
Other Study ID Numbers: 10070341
Study First Received: November 4, 2011
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
NAVA
neurally adjusted ventilatory support
lung injury
ventilation
lung volume distribution
oxygen cost of breathing

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014