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| Name | Class |
|---|---|
| Rotary | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAVA-PS | Experimental | noninvasive NAVA first for 15 minutes and then PSV for 15 minutes |
|
| PS-NAVA | Experimental | noninvasive PSV first for 15 minutes and then NAVA for 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| noninvasive respiratory support with NAVA mode and PSV | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | last 5-min of each 15-min trial |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | last 5-min of each 15-min trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Suk Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | Gyeonggi-do | 463-707 | South Korea | ||
| Seoul National University Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26178463 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PS-NAVA | noninvasive PSV first for 15 minutes and then NAVA for 15 minutes crossover of noninvasive respiratory support with NAVA mode and PSV |
| FG001 | NAVA-PS | noninvasive NAVA first for 15 minutes and then PSV for 15 minutes crossover of noninvasive respiratory support with NAVA mode and PSV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Enrolled Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ms | last 5-min of each 15-min trial |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NIV-NAVA | non-invasive NAVA |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment | Bradycardia longer than 2 min |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Han-Suk Kim | Seoul National University College of Medicine | 82-2-2072-1696 | kimhans@snu.ac.kr |
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| Minute Ventilation Volume |
inspiratory tidal volume / respiratory rate |
| last 5-min of each 15-min trial |
| 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 |
| Swing EAdi | last 5-min of each 15-min trial |
| Leakage | [TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume) | last 5-min of each 15-min trial |
| All Asynchrony Events | last 5-min of each 15-min trial |
| Asynchrony Index | total number of each event per minute
| last 5-min of each 15-min trial |
| SpO2 | transcutaneous peripheral saturation of oxygen by pulse oximeter | last 5-min of each 15-min trial |
| Heart Rate | last 5-min of each 15-min trial |
| Blood Pressure | systolic, diastolic and mean blood pressure measured by non-invasive cuff | last 5-min of each 15-min trial |
| Respiratory Rate | last 5-min of each 15-min trial |
| Seoul |
| 110-744 |
| South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| weeks of gestation |
|
| Age, Continuous | Median | Inter-Quartile Range | day |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Birth weight | Median | Inter-Quartile Range | g |
|
| Units | Counts |
|---|
| Participants |
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|
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| Secondary | 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 | Posted | Mean | Standard Deviation | percentage of neural inspiratory time | last 5-min of each 15-min trial |
|
|
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| Secondary | Minute Ventilation Volume | inspiratory tidal volume / respiratory rate | Posted | Mean | Standard Deviation | mL/kg/min | last 5-min of each 15-min trial |
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| Secondary | Peak Inspiratory Pressure | Posted | Mean | Standard Deviation | cmH2O | last 5-min of each 15-min trial |
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| Secondary | Pneumatic Respiratory Rate | Posted | Mean | Standard Deviation | breaths per min | last 5-min of each 15-min trial |
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| Secondary | Maximum EAdi | Posted | Mean | Standard Deviation | uV | last 5-min of each 15-min trial |
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| Secondary | Swing EAdi | Posted | Mean | Standard Deviation | uV | last 5-min of each 15-min trial |
|
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| Secondary | Leakage | [TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume) | Posted | Mean | Standard Deviation | percentage of inspiratory tidal volume | last 5-min of each 15-min trial |
|
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| Secondary | All Asynchrony Events | Posted | Median | Inter-Quartile Range | events per min | last 5-min of each 15-min trial |
|
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| Secondary | Asynchrony Index | total number of each event per minute
| Posted | Median | Inter-Quartile Range | percentage of neural respiration | last 5-min of each 15-min trial |
|
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|
|
| Secondary | SpO2 | transcutaneous peripheral saturation of oxygen by pulse oximeter | Not Posted | last 5-min of each 15-min trial |
| Secondary | Heart Rate | Not Posted | last 5-min of each 15-min trial |
| Secondary | Blood Pressure | systolic, diastolic and mean blood pressure measured by non-invasive cuff | Not Posted | last 5-min of each 15-min trial |
| Secondary | Respiratory Rate | Not Posted | last 5-min of each 15-min trial |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | NIV-PS | non-invasive PS | 0 | 15 | 1 | 15 |
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