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

Phase 2

Completed

• Conditions: Infant, Preterm
• Interventions: Procedure: neurally adjusted ventilatory assist (NAVA) ventilator mode

• Registration Number: NCT01389882
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2011-09-18
• Results First Submitted QC: 2011-09-21
• Results First Posted: 2011-10-28
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-05
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• preterm infants mechanically ventilated
• ventilatory set frequency is under 25
• with informed consent of their parents

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ventilator assist	neurally adjusted ventilatory assist (NAVA) ventilator mode	-

Primary Outcome Measures

Name	Time	Method
Peak Inspiratory Pressure	four hours	peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of