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Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01877720
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Rotary
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants Device: noninvasive respiratory support with NAVA mode and PSV Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: NAVA-PS
noninvasive NAVA first for 15 minutes and then PSV for 15 minutes
Device: noninvasive respiratory support with NAVA mode and PSV
Experimental: PS-NAVA
noninvasive PSV first for 15 minutes and then NAVA for 15 minutes
Device: noninvasive respiratory support with NAVA mode and PSV



Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization
    2. auto-triggering: a cycle delivered by the ventilator without EAdi signal
    3. premature cycling
    4. delayed cycling: VPT > NIT x2
    5. 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 ]


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877720


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Bundang, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-744
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Rotary
Investigators
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Principal Investigator: Han-Suk Kim, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Han-Suk Kim, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01877720     History of Changes
Other Study ID Numbers: NIV-NAVA Physiologic Study
First Posted: June 14, 2013    Key Record Dates
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015
Last Verified: November 2015

Keywords provided by Han-Suk Kim, Seoul National University Hospital:
Preterm infant less than 32 weeks of gestation age
intubated more than 48 hours after birth
postextubation

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications