ClinicalTrials.gov
ClinicalTrials.gov Menu

Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01877720
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Rotary
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Intervention Device: noninvasive respiratory support with NAVA mode and PSV
Enrollment 16

Recruitment Details  
Pre-assignment Details  
Arm/Group Title PS-NAVA NAVA-PS
Hide Arm/Group Description

noninvasive PSV first for 15 minutes and then NAVA for 15 minutes

crossover of noninvasive respiratory support with NAVA mode and PSV

noninvasive NAVA first for 15 minutes and then PSV for 15 minutes

crossover of noninvasive respiratory support with NAVA mode and PSV

Period Title: Overall Study
Started 8 8
1st Intervention 7 8
2nd Intervention 7 8
Completed 7 8
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Total Enrolled Patients
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Weeks of gestation
Gestational age Number Analyzed 15 participants
27.1
(26.0 to 28.2)
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Day
Postnatal age at study Number Analyzed 15 participants
25
(17.5 to 32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
Birth weight  
Median (Inter-Quartile Range)
Unit of measure:  g
Number Analyzed 15 participants
790
(675 to 1215)
1.Primary Outcome
Title Trigger Delay
Hide Description 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.
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: ms
35.2  (8.3) 294.6  (101.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
2.Secondary Outcome
Title Ti_excess (Inspiratory Time in Excess)
Hide Description

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

Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of neural inspiratory time
32.2  (11.4) 56.8  (25.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
3.Secondary Outcome
Title Minute Ventilation Volume
Hide Description inspiratory tidal volume / respiratory rate
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mL/kg/min
114.9  (47.0) 124.1  (42.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
4.Secondary Outcome
Title Peak Inspiratory Pressure
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: cmH2O
12.3  (1.5) 14.7  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
5.Secondary Outcome
Title Pneumatic Respiratory Rate
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: breaths per min
46.3  (12.6) 33.3  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
6.Secondary Outcome
Title Maximum EAdi
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: uV
12.6  (6.3) 16.6  (8.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
7.Secondary Outcome
Title Swing EAdi
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: uV
8.8  (4.8) 12.2  (8.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
8.Secondary Outcome
Title Leakage
Hide Description [TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of inspiratory tidal volume
87.6  (8.3) 86.7  (6.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
9.Secondary Outcome
Title All Asynchrony Events
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: events per min
8.2
(3.0 to 11.5)
47.6
(38.1 to 61.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
10.Secondary Outcome
Title Asynchrony Index
Hide Description

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
Time Frame last 5-min of each 15-min trial
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description:
non-invasive NAVA
non-invasive PS
Overall Number of Participants Analyzed 15 15
Median (Inter-Quartile Range)
Unit of Measure: percentage of neural respiration
19.7
(9.6 to 23.4)
73.9
(71.5 to 78.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NIV-NAVA, NIV-PS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon signed-rank test
Comments [Not Specified]
11.Secondary Outcome
Title SpO2
Time Frame last 5-min of each 15-min trial
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Blood Pressure
Hide Description systolic, diastolic and mean blood pressure measured by non-invasive cuff
Time Frame last 5-min of each 15-min trial
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Respiratory Rate
Hide Description [Not Specified]
Time Frame last 5-min of each 15-min trial
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NIV-NAVA NIV-PS
Hide Arm/Group Description non-invasive NAVA non-invasive PS
All-Cause Mortality
NIV-NAVA NIV-PS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NIV-NAVA NIV-PS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NIV-NAVA NIV-PS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/15 (6.67%)    
Cardiac disorders     
Bradycardia  [1]  0/15 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
Bradycardia longer than 2 min
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Han-Suk Kim
Organization: Seoul National University College of Medicine
Phone: 82-2-2072-1696
Responsible Party: Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01877720     History of Changes
Other Study ID Numbers: NIV-NAVA Physiologic Study
First Submitted: June 5, 2013
First Posted: June 14, 2013
Results First Submitted: May 28, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015