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Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

Primary Purpose

Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
noninvasive respiratory support with NAVA mode and PSV
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants focused on measuring Preterm infant less than 32 weeks of gestation age, intubated more than 48 hours after birth, postextubation

Eligibility Criteria

3 Days - 3 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Children's Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NAVA-PS

PS-NAVA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Minute Ventilation Volume
inspiratory tidal volume / respiratory rate
Peak Inspiratory Pressure
Pneumatic Respiratory Rate
Maximum EAdi
Swing EAdi
Leakage
[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)
All Asynchrony Events
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 triggering Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100
SpO2
transcutaneous peripheral saturation of oxygen by pulse oximeter
Heart Rate
Blood Pressure
systolic, diastolic and mean blood pressure measured by non-invasive cuff
Respiratory Rate

Full Information

First Posted
June 5, 2013
Last Updated
November 18, 2015
Sponsor
Seoul National University Hospital
Collaborators
Rotary
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1. Study Identification

Unique Protocol Identification Number
NCT01877720
Brief Title
Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants
Official Title
Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Rotary

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAVA-PS
Arm Type
Experimental
Arm Description
noninvasive NAVA first for 15 minutes and then PSV for 15 minutes
Arm Title
PS-NAVA
Arm Type
Experimental
Arm Description
noninvasive PSV first for 15 minutes and then NAVA for 15 minutes
Intervention Type
Device
Intervention Name(s)
noninvasive respiratory support with NAVA mode and PSV
Primary Outcome Measure Information:
Title
Trigger Delay
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
Secondary Outcome Measure Information:
Title
Ti_excess (Inspiratory Time in Excess)
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
Title
Minute Ventilation Volume
Description
inspiratory tidal volume / respiratory rate
Time Frame
last 5-min of each 15-min trial
Title
Peak Inspiratory Pressure
Time Frame
last 5-min of each 15-min trial
Title
Pneumatic Respiratory Rate
Time Frame
last 5-min of each 15-min trial
Title
Maximum EAdi
Time Frame
last 5-min of each 15-min trial
Title
Swing EAdi
Time Frame
last 5-min of each 15-min trial
Title
Leakage
Description
[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)
Time Frame
last 5-min of each 15-min trial
Title
All Asynchrony Events
Time Frame
last 5-min of each 15-min trial
Title
Asynchrony Index
Description
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 triggering Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100
Time Frame
last 5-min of each 15-min trial
Title
SpO2
Description
transcutaneous peripheral saturation of oxygen by pulse oximeter
Time Frame
last 5-min of each 15-min trial
Title
Heart Rate
Time Frame
last 5-min of each 15-min trial
Title
Blood Pressure
Description
systolic, diastolic and mean blood pressure measured by non-invasive cuff
Time Frame
last 5-min of each 15-min trial
Title
Respiratory Rate
Time Frame
last 5-min of each 15-min trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Suk Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Bundang
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26178463
Citation
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.
Results Reference
derived

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Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

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