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

NCT ID: NCT01504373

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2020-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NAVA-PSV

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

Neurally Adjusted Ventilatory Assist (NAVA)

Intervention Type: DEVICE

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.

Neurally Adjusted Ventilatory Assist (NAVA)

Intervention Type: DEVICE

Subjects will be placed in the NAVA mode of ventilation.

Interventions

Neurally Adjusted Ventilatory Assist (NAVA)

Subjects will be placed in the NAVA mode of ventilation.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jordan Rettig

Associate, Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10070341

Identifier Type: -

Identifier Source: org_study_id