Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Primary Purpose
Infant, Preterm
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
neurally adjusted ventilatory assist (NAVA) ventilator mode
Sponsored by

About this trial
This is an interventional supportive care trial for Infant, Preterm focused on measuring mechanical ventilation, diaphragm electrical activity, pressure support
Eligibility Criteria
Inclusion Criteria:
- preterm infants mechanically ventilated
- ventilatory set frequency is under 25
- with informed consent of their parents
Exclusion Criteria:
- major congenital anomalies
- patients without self respiratory effort
- use of sedative or anesthetic drugs
- grade III or IV intraventricular hemorrhage
- phrenic nerve palsy or insufficiency
Sites / Locations
- Seoul National University Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ventilator assist
Arm Description
Outcomes
Primary Outcome Measures
Peak Inspiratory Pressure
peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode
Secondary Outcome Measures
Mean Airway Pressure
mean airway pressure measured by a ventilator for 4 hours with each ventilator mode
Minute Ventilation
Minute ventilation measured by a ventilator for 4 hours with each ventilator mode
Expiratory Tidal Volume
Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode
Dynamic Compliance
Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode
Work of Breathing
Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode
Peak EAdi
Peak electrical activity of the diaphragm
Fraction of Oxygen
Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode
Capillary Blood pH
Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode
Capillary Blood pCO2
Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode
Capillary Blood pO2
Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode
Capillary Blood HCO3
Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode
Full Information
NCT ID
NCT01389882
First Posted
July 1, 2011
Last Updated
January 5, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01389882
Brief Title
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
Official Title
Application of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants and Assessment of Its Benefits Compared to Synchronized Intermittent Mandatory Ventilation (SIMV) With Pressure Support (PS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
Detailed Description
The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.
Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Preterm
Keywords
mechanical ventilation, diaphragm electrical activity, pressure support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ventilator assist
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
neurally adjusted ventilatory assist (NAVA) ventilator mode
Other Intervention Name(s)
Servo-i (Maquet Critical Care AB, Solna, Sweden)
Intervention Description
Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable.
Primary Outcome Measure Information:
Title
Peak Inspiratory Pressure
Description
peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Secondary Outcome Measure Information:
Title
Mean Airway Pressure
Description
mean airway pressure measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Title
Minute Ventilation
Description
Minute ventilation measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Title
Expiratory Tidal Volume
Description
Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Title
Dynamic Compliance
Description
Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Title
Work of Breathing
Description
Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Title
Peak EAdi
Description
Peak electrical activity of the diaphragm
Time Frame
four hours
Title
Fraction of Oxygen
Description
Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode
Time Frame
four hours
Title
Capillary Blood pH
Description
Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode
Time Frame
four hours
Title
Capillary Blood pCO2
Description
Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode
Time Frame
four hours
Title
Capillary Blood pO2
Description
Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode
Time Frame
four hours
Title
Capillary Blood HCO3
Description
Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode
Time Frame
four hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
preterm infants mechanically ventilated
ventilatory set frequency is under 25
with informed consent of their parents
Exclusion Criteria:
major congenital anomalies
patients without self respiratory effort
use of sedative or anesthetic drugs
grade III or IV intraventricular hemorrhage
phrenic nerve palsy or insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Suk Kim, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-733
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants
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