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Completed

NCT Number: NCT01877720

Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).

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Key information

Conditions

Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants

Age range

3 day–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Bundang Hospital, Bundang, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • preterm infants less than 32 weeks of gestational age
  • intubated more than 48 hours after birth
  • subjected to extubation with minimal ventilator setting (mean airway pressure < 7cmH2O + peak inspiratory pressure < 13 cmH2O + FiO2 < 0.4 + respiratory rate < 35/min)
  • with informed consent from parents

Exclusion criteria

  • with major congenital anomalies
  • use of sedative or anesthetic drugs
  • hemodynamic instability
  • grade 3 or higher intraventricular hemorrhage
  • phrenic nerve palsy

Treatment and study plan

noninvasive respiratory support with NAVA mode and PSV

Device

Primary outcomes

  1. Trigger Delay

    Time frame: last 5-min of each 15-min trial

    Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.

Secondary outcomes

  1. Ti_excess (Inspiratory Time in Excess)

    Time frame: last 5-min of each 15-min trial

    Ti_excess = (VPT-NIT)/NIT

    VPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value

  2. Minute Ventilation Volume

    Time frame: last 5-min of each 15-min trial

    inspiratory tidal volume / respiratory rate

  3. Peak Inspiratory Pressure

    Time frame: last 5-min of each 15-min trial

  4. Pneumatic Respiratory Rate

    Time frame: last 5-min of each 15-min trial

  5. Maximum EAdi

    Time frame: last 5-min of each 15-min trial

  6. Swing EAdi

    Time frame: last 5-min of each 15-min trial

  7. Leakage

    Time frame: last 5-min of each 15-min trial

    [TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)

  8. All Asynchrony Events

    Time frame: last 5-min of each 15-min trial

  9. Asynchrony Index

    Time frame: last 5-min of each 15-min trial

    total number of each event per minute

    • ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization
    • auto-triggering: a cycle delivered by the ventilator without EAdi signal
    • premature cycling
    • delayed cycling: VPT > NIT x2
    • double triggering
    • Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100

  10. SpO2

    Time frame: last 5-min of each 15-min trial

    transcutaneous peripheral saturation of oxygen by pulse oximeter

  11. Heart Rate

    Time frame: last 5-min of each 15-min trial

  12. Blood Pressure

    Time frame: last 5-min of each 15-min trial

    systolic, diastolic and mean blood pressure measured by non-invasive cuff

  13. Respiratory Rate

    Time frame: last 5-min of each 15-min trial

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Rotary

Registry information

Official study title

Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2013
Registry last updated
Dec 23, 2015

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

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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.