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Clinical Trials/NCT01877720
NCT01877720
Completed
Phase 2

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

Seoul National University Hospital3 sites in 1 country16 target enrollmentNovember 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Sponsor
Seoul National University Hospital
Enrollment
16
Locations
3
Primary Endpoint
Trigger Delay
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
April 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Han-Suk Kim

MD, PhD

Seoul National University Hospital

Eligibility 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

Outcomes

Primary Outcomes

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

  • Ti_excess (Inspiratory Time in Excess)(last 5-min of each 15-min trial)
  • Heart Rate(last 5-min of each 15-min trial)
  • Pneumatic Respiratory Rate(last 5-min of each 15-min trial)
  • Leakage(last 5-min of each 15-min trial)
  • Blood Pressure(last 5-min of each 15-min trial)
  • SpO2(last 5-min of each 15-min trial)
  • Respiratory Rate(last 5-min of each 15-min trial)
  • Minute Ventilation Volume(last 5-min of each 15-min trial)
  • Peak Inspiratory Pressure(last 5-min of each 15-min trial)
  • Maximum EAdi(last 5-min of each 15-min trial)
  • Swing EAdi(last 5-min of each 15-min trial)
  • All Asynchrony Events(last 5-min of each 15-min trial)
  • Asynchrony Index(last 5-min of each 15-min trial)

Study Sites (3)

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