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

November 13, 2022 updated by: Jordan Rettig, Boston Children's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline regional distribution of ventilation after the 4th hour and after 8th hour
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.
Change from baseline oxygen cost of breathing and carbon dioxide production after the 4th hour and after the 8th hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Monitored/recorded continuously for duration of study (8 hours total)
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.
Monitored/recorded every 30 seconds for duration of study (8 hours total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Arnold, MD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10070341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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