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Completed

NCT Number: NCT01389882

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

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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Key information

Conditions

Infant, Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Children's Hospital

Seoul, 110-733, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neurally adjusted ventilatory assist (NAVA) ventilator mode

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.

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

Primary outcomes

  1. Peak Inspiratory Pressure

    Time frame: four hours

    peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode

Secondary outcomes

  1. Mean Airway Pressure

    Time frame: four hours

    mean airway pressure measured by a ventilator for 4 hours with each ventilator mode

  2. Minute Ventilation

    Time frame: four hours

    Minute ventilation measured by a ventilator for 4 hours with each ventilator mode

  3. Expiratory Tidal Volume

    Time frame: four hours

    Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode

  4. Dynamic Compliance

    Time frame: four hours

    Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode

  5. Work of Breathing

    Time frame: four hours

    Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode

  6. Peak EAdi

    Time frame: four hours

    Peak electrical activity of the diaphragm

  7. Fraction of Oxygen

    Time frame: four hours

    Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode

  8. Capillary Blood pH

    Time frame: four hours

    Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode

  9. Capillary Blood pCO2

    Time frame: four hours

    Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode

  10. Capillary Blood pO2

    Time frame: four hours

    Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode

  11. Capillary Blood HCO3

    Time frame: four hours

    Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2011
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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