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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01877720

Enrollment

Registered

2013-06-14

Start date

2013-11-30

Completion date

2014-04-30

Last updated

2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants

Keywords

Preterm infant less than 32 weeks of gestation age, intubated more than 48 hours after birth, postextubation

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).

Interventions

DEVICEnoninvasive respiratory support with NAVA mode and PSV

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Days to 3 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Blood Pressure	last 5-min of each 15-min trial	systolic, diastolic and mean blood pressure measured by non-invasive cuff
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
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	—
Pneumatic Respiratory Rate	last 5-min of each 15-min trial	—
Maximum EAdi	last 5-min of each 15-min trial	—
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)
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
SpO2	last 5-min of each 15-min trial	transcutaneous peripheral saturation of oxygen by pulse oximeter
Heart Rate	last 5-min of each 15-min trial	—
Swing EAdi	last 5-min of each 15-min trial	—

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Total Enrolled Patients	15
Total	15

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0

Baseline characteristics

Characteristic	Total Enrolled Patients
Age, Continuous Gestational age	27.1 weeks of gestation
Age, Continuous Postnatal age at study	25 day
Birth weight	790 g
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 15	1 / 15
serious Total, serious adverse events	0 / 15	0 / 15

Outcome results

Primary

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.