Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Phase 2

Completed

• Conditions: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
• Interventions: Device: noninvasive respiratory support with NAVA mode and PSV

• Registration Number: NCT01877720
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-14
• Study Start: 2013-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-05-28
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Results First Posted: 2015-12-23
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NAVA-PS	noninvasive respiratory support with NAVA mode and PSV	noninvasive NAVA first for 15 minutes and then PSV for 15 minutes
PS-NAVA	noninvasive respiratory support with NAVA mode and PSV	noninvasive PSV first for 15 minutes and then NAVA for 15 minutes

Primary Outcome Measures

Name	Time	Method
Trigger Delay	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

Name	Time	Method
Ti_excess (Inspiratory Time in Excess)	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
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	\[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)\]/TVi (inspiratory tidal volume)
Blood Pressure	last 5-min of each 15-min trial	systolic, diastolic and mean blood pressure measured by non-invasive cuff
SpO2	last 5-min of each 15-min trial	transcutaneous peripheral saturation of oxygen by pulse oximeter
Respiratory Rate	last 5-min of each 15-min trial
Minute Ventilation Volume	last 5-min of each 15-min trial	inspiratory tidal volume / respiratory rate
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	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

Trial Locations

Locations (3)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Bundang, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of