Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants

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)

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).

Study Overview

• Status: Completed
• Conditions: Infant, Preterm
• Intervention / Treatment: Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-733
    • Seoul National University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ventilator assist

Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode; 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.; Other Names: Servo-i (Maquet Critical Care AB, Solna, Sweden)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Inspiratory Pressure	peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode	four hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Airway Pressure	mean airway pressure measured by a ventilator for 4 hours with each ventilator mode	four hours
Minute Ventilation	Minute ventilation measured by a ventilator for 4 hours with each ventilator mode	four hours
Expiratory Tidal Volume	Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode	four hours
Dynamic Compliance	Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode	four hours
Work of Breathing	Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode	four hours
Peak EAdi	Peak electrical activity of the diaphragm	four hours
Fraction of Oxygen	Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode	four hours
Capillary Blood pH	Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode	four hours
Capillary Blood pCO2	Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode	four hours
Capillary Blood pO2	Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode	four hours
Capillary Blood HCO3	Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode	four hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Han Suk Kim, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2012
• Last Update Submitted That Met QC Criteria: January 5, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: mechanical ventilation; pressure support; diaphragm electrical activity
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: VENT-01-NAVA