Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (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).

Study Overview

• Status: Completed
• Conditions: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
• Intervention / Treatment: Device: noninvasive respiratory support with NAVA mode and PSV

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Children's Hospital
  • Gyeonggi-do
    • Bundang, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trigger Delay	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.	last 5-min of each 15-min trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ti_excess (Inspiratory Time in Excess)	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	last 5-min of each 15-min trial
Minute Ventilation Volume	inspiratory tidal volume / respiratory rate	last 5-min of each 15-min trial
Peak Inspiratory Pressure		last 5-min of each 15-min trial
Pneumatic Respiratory Rate		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
Leakage	[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)	last 5-min of each 15-min trial
All Asynchrony Events		last 5-min of each 15-min trial
Asynchrony Index	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 triggeringAsynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100	last 5-min of each 15-min trial
SpO2	transcutaneous peripheral saturation of oxygen by pulse oximeter	last 5-min of each 15-min trial
Heart Rate		last 5-min of each 15-min trial
Blood Pressure	systolic, diastolic and mean blood pressure measured by non-invasive cuff	last 5-min of each 15-min trial
Respiratory Rate		last 5-min of each 15-min trial

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Rotary
• Investigators: Principal Investigator: Han-Suk Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Preterm infant less than 32 weeks of gestation age; intubated more than 48 hours after birth; postextubation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NIV-NAVA Physiologic Study