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The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).
The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.
Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ventilator assist | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurally adjusted ventilatory assist (NAVA) ventilator mode | Procedure | Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Inspiratory Pressure | peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode | four hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Airway Pressure | mean airway pressure measured by a ventilator for 4 hours with each ventilator mode | four hours |
| Minute Ventilation | Minute ventilation measured by a ventilator for 4 hours with each ventilator mode |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han Suk Kim, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | 110-733 | South Korea |
26 patients enrolled; 24 assigned to randomization and 2 excluded (1 extubated prior to the study and 1 developed exclusion criteria)
Participants recruited from a neonatal intensive care unit (NICU) of Seoul National University Hospital, in Seoul, Republic of Korea between March 2011 to July 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | SN Group | Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA) |
| FG001 | NS Group | NAVA first, then SIMV with PS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SN Group | Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA) |
| BG001 | NS Group | NAVA first, then SIMV with PS |
| 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 | Peak Inspiratory Pressure | peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | cmH2O | four hours |
|
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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 | SN Group | Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA) |
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Two patients were excluded prior to the study and five patients were interrupted the study because of a developed exclusion criterion during the protocol. Because of eliminated participants, the number of subjects analyzed was reduced.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juyoung Lee | Seoul National University Hospital | lamb4122@snu.ac.kr | lamb4122@snu.ac.kr |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059725 | Interactive Ventilatory Support |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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|
|
| four hours |
| Expiratory Tidal Volume | Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode | four hours |
| Dynamic Compliance | Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode | four hours |
| Work of Breathing | Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode | four hours |
| Peak EAdi | Peak electrical activity of the diaphragm | four hours |
| Fraction of Oxygen | Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode | four hours |
| Capillary Blood pH | Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode | four hours |
| Capillary Blood pCO2 | Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode | four hours |
| Capillary Blood pO2 | Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode | four hours |
| Capillary Blood HCO3 | Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode | four hours |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age | Mean | Standard Deviation | days |
|
| Birth Weight | Median | Full Range | g |
|
| Birth Height | Mean | Standard Deviation | cm |
|
| Study Day Postmenstrual Age | Mean | Standard Deviation | days |
|
| Study Day Body Weight | Median | Full Range | g |
|
| Capillary Blood pH | Mean | Standard Deviation | pH |
|
| Capillary Blood pCO2 | Mean | Standard Deviation | mmHg |
|
| Capillary Blood pO2 | Mean | Standard Deviation | mmHg |
|
| Capillary Blood HCO3 | Mean | Standard Deviation | mmol/L |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Mean Airway Pressure | mean airway pressure measured by a ventilator for 4 hours with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | cmH2O | four hours |
|
|
|
|
| Secondary | Minute Ventilation | Minute ventilation measured by a ventilator for 4 hours with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | L/min/Kg | four hours |
|
|
|
|
| Secondary | Expiratory Tidal Volume | Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | mL/Kg | four hours |
|
|
|
|
| Secondary | Dynamic Compliance | Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | mL/cmH2O | four hours |
|
|
|
|
| Secondary | Work of Breathing | Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Median | Full Range | mJ/L | four hours |
|
|
|
|
| Secondary | Peak EAdi | Peak electrical activity of the diaphragm | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | uV | four hours |
|
|
|
|
| Secondary | Fraction of Oxygen | Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode | Posted | Median | Full Range | percentage of concentration | four hours |
|
|
|
|
| Secondary | Capillary Blood pH | Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | pH | four hours |
|
|
|
|
| Secondary | Capillary Blood pCO2 | Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | mmHg | four hours |
|
|
|
|
| Secondary | Capillary Blood pO2 | Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | mmHg | four hours |
|
|
|
|
| Secondary | Capillary Blood HCO3 | Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode | The analysis was "per protocol". 19 patients who had completed the study was used for the analysis. | Posted | Mean | Standard Deviation | mmol/L | four hours |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | NS Group | NAVA first, then SIMV with PS | 0 | 11 | 0 | 11 |
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| D000091642 | Urogenital Diseases |