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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Infant, Preterm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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ventilator assist

Group Type EXPERIMENTAL

neurally adjusted ventilatory assist (NAVA) ventilator mode

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Servo-i (Maquet Critical Care AB, Solna, Sweden)

Eligibility Criteria

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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

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No