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Trial Outcomes & Findings for Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants (NCT NCT01877720)

NCT ID: NCT01877720

Last Updated: 2015-12-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

16 participants

Primary outcome timeframe

last 5-min of each 15-min trial

Results posted on

2015-12-23

Participant Flow

Participant milestones

Participant milestones
Measure
PS-NAVA
noninvasive PSV first for 15 minutes and then NAVA for 15 minutes crossover of noninvasive respiratory support with NAVA mode and PSV
NAVA-PS
noninvasive NAVA first for 15 minutes and then PSV for 15 minutes crossover of noninvasive respiratory support with NAVA mode and PSV
Overall Study
STARTED
8
8
Overall Study
1st Intervention
7
8
Overall Study
2nd Intervention
7
8
Overall Study
COMPLETED
7
8
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
PS-NAVA
noninvasive PSV first for 15 minutes and then NAVA for 15 minutes crossover of noninvasive respiratory support with NAVA mode and PSV
NAVA-PS
noninvasive NAVA first for 15 minutes and then PSV for 15 minutes crossover of noninvasive respiratory support with NAVA mode and PSV
Overall Study
Adverse Event
1
0

Baseline Characteristics

Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Enrolled Patients
n=15 Participants
Age, Continuous
Gestational age
27.1 weeks of gestation
n=5 Participants
Age, Continuous
Postnatal age at study
25 day
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Birth weight
790 g
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Trigger Delay
35.2 ms
Standard Deviation 8.3
294.6 ms
Standard Deviation 101.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Ti_excess (Inspiratory Time in Excess)
32.2 percentage of neural inspiratory time
Standard Deviation 11.4
56.8 percentage of neural inspiratory time
Standard Deviation 25.2

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

inspiratory tidal volume / respiratory rate

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Minute Ventilation Volume
114.9 mL/kg/min
Standard Deviation 47.0
124.1 mL/kg/min
Standard Deviation 42.4

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Peak Inspiratory Pressure
12.3 cmH2O
Standard Deviation 1.5
14.7 cmH2O
Standard Deviation 2.7

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Pneumatic Respiratory Rate
46.3 breaths per min
Standard Deviation 12.6
33.3 breaths per min
Standard Deviation 13.1

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Maximum EAdi
12.6 uV
Standard Deviation 6.3
16.6 uV
Standard Deviation 8.7

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Swing EAdi
8.8 uV
Standard Deviation 4.8
12.2 uV
Standard Deviation 8.7

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

\[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)\]/TVi (inspiratory tidal volume)

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Leakage
87.6 percentage of inspiratory tidal volume
Standard Deviation 8.3
86.7 percentage of inspiratory tidal volume
Standard Deviation 6.8

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
All Asynchrony Events
8.2 events per min
Interval 3.0 to 11.5
47.6 events per min
Interval 38.1 to 61.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
NIV-NAVA
n=15 Participants
non-invasive NAVA
NIV-PS
n=15 Participants
non-invasive PS
Asynchrony Index
19.7 percentage of neural respiration
Interval 9.6 to 23.4
73.9 percentage of neural respiration
Interval 71.5 to 78.1

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

transcutaneous peripheral saturation of oxygen by pulse oximeter

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

systolic, diastolic and mean blood pressure measured by non-invasive cuff

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: last 5-min of each 15-min trial

Outcome measures

Outcome data not reported

Adverse Events

NIV-NAVA

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

NIV-PS

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
NIV-NAVA
n=15 participants at risk
non-invasive NAVA
NIV-PS
n=15 participants at risk
non-invasive PS
Cardiac disorders
Bradycardia
0.00%
0/15
6.7%
1/15 • Number of events 1

Additional Information

Dr. Han-Suk Kim

Seoul National University College of Medicine

Phone: 82-2-2072-1696

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place