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Preterm infants undergoing mechanical ventilation often present with respiratory instability which leads to fluctuations in ventilation and oxygenation. In conventional modes of mechanical ventilation used in these patients, the ventilator delivers breaths at a set rate and a constant peak inspiratory pressure.
We have demonstrated that spontaneous episodes of hypoxemia in mechanically ventilated preterm infants are frequently triggered by a loss in end-expiratory lung volume followed by decrease in tidal volume. This is due to a reduction in respiratory system compliance and increase in airway resistance.
Volume Guarantee ventilation is a mode of ventilation in which ventilator measures the exhaled tidal volume of each ventilator breath and automatically adjusts the peak inspiratory pressure to deliver the set tidal volume. We have previously shown that Volume Guarantee reduced the severity and duration of hypoxemia episodes during a period of 2 hours in preterm infants The study hypothesis is that Volume Guarantee ventilation will decrease the duration of episodes of hypoxemia when compared to conventional mechanical ventilation during routine clinical conditions and over longer periods of time.
The objective of the study is to evaluate the effects of Volume Guarantee on the duration, severity and frequency of episodes of hypoxemia in mechanically ventilated preterm infants who present with frequent hypoxemia episodes in comparison to conventional ventilation over two periods of 24 hours each and under routine clinical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A: Conventional-Volume Guarantee | Active Comparator | This is a crossover study. Infants will be assigned to one of two sequences. Sequence A consists of a 24-hour period during which the infant receives conventional mechanical ventilation followed by a second 24 hour period during which the infant receives volume guarantee ventilation. |
|
| Sequence B: Volume Guarantee-Conventional | Active Comparator | This is a crossover study. Infants will be assigned to one of two sequences. Sequence B consists of a 24-hour period during which the infant receives volume guarantee ventilation followed by a second 24 hour period during which the infant receives conventional mechanical ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequence A: Conventional-Volume Guarantee | Device | This is a crossover study. Infants will be randomly assigned to one of two sequences. In sequence A, the infant will undergo a 24-hour period of conventional mechanical ventilation followed by a 24 hour period of volume guarantee ventilation. Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA). During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team. During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent With Arterial Oxygen Saturation < 75% | Percentage of time spent with arterial oxygen saturation < 75% | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Severe Hypoxemia Episodes | Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 < 75% lasting for at least 20 seconds. | 24 hours |
| Frequency of Hypoxemia Episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of Inspired Oxygen (FiO2) | Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods. Reported as median and inter-quartile range of all subjects. | 24 hours |
| Tidal Volume |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelson Claure, M.Sc., Ph.D. | University of Miami | Principal Investigator |
| Eduardo Bancalari, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newborn Intensitve Care Unit at Holtz Children's Hospital of Jackson Health System | Miami | Florida | 33136 | United States |
42 infants were screened. Of these, 9 declined participation and 3 did not meet inclusion criteria.
30 infants were enrolled (consented). Of these, 4 infants became ineligible after consent and were not studied.
26 enrolled infants were studied.
This study was conducted at the Project NewBorn Neonatal Intensive Care Unit of the Jackson Memorial Hospital/University of Miami Medical Center. Subjects were recruited into the study between December, 2012 and September, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A: Conventional-Volume Guarantee | This is a crossover study. Each patient is randomly assigned to one of two sequences. Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation. |
| FG001 | Sequence B: Volume Guarantee-Conventional | This is a crossover study. Each patient is randomly assigned to one of two sequences. Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 24 Hours |
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| Second 24 Hours |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Population | This is a crossover study. Infants were randomly assigned to one of two sequences. Sequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation. Sequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Time Spent With Arterial Oxygen Saturation < 75% | Percentage of time spent with arterial oxygen saturation < 75% | Posted | Median | Inter-Quartile Range | % of time | 24 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 | Conventional Mechanical Ventilation Period | This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation. These data represent the 24 hours of Conventional Mechanical Ventilation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased PaCO2 requiring high frequency ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nelson Claure, MSc, PhD, Director Neonatal Pulmonary Research Lab | University of Miami School of Medicine, Dept. of Pediatrics - Div. of Neonatology | 305 585 6408 | nclaure@miami.edu |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Sequence B: Volume Guarantee-Conventional | Device | This is a crossover study. Infants will be randomly assigned to one of two sequences. In sequence B, the infant will undergo a 24-hour period of volume guarantee ventilation followed by a 24 hour period of conventional mechanical ventilation. Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA). During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team. During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study. |
|
Frequency of hypoxemia episodes defined as episodes with arterial saturation < 85% for at least 20 seconds
| 24 hours |
| Duration of Hypoxemia Episodes | Duration of hypoxemia episodes of arterial saturation < 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects. | 24 hours |
The mean exhaled tidal volume of mechanical breaths.
| 24 hours |
| NOT COMPLETED |
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| days |
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| Gender | Count of Participants | Participants |
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| Gestational age | Mean | Standard Deviation | weeks |
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| Birth weight | Mean | Standard Deviation | grams |
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| Ventilator mandatory rate | Mean | Standard Deviation | breaths per minute |
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| Peak inspiratory pressure | Mean | Standard Deviation | cm H2O |
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| Pressure support | Mean | Standard Deviation | cm H2O |
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| Positive end expiratory pressure | Mean | Standard Deviation | cm H2O |
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| Fraction of Inspired Oxygen | Mean | Standard Deviation | fraction |
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| Secondary | Frequency of Severe Hypoxemia Episodes | Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 < 75% lasting for at least 20 seconds. | Posted | Median | Inter-Quartile Range | severe hypoxemia episodes per hour | 24 hours |
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| Secondary | Frequency of Hypoxemia Episodes | Frequency of hypoxemia episodes defined as episodes with arterial saturation < 85% for at least 20 seconds | Posted | Median | Inter-Quartile Range | hypoxemia episodes per hour | 24 hours |
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| Secondary | Duration of Hypoxemia Episodes | Duration of hypoxemia episodes of arterial saturation < 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects. | Posted | Median | Inter-Quartile Range | seconds | 24 hours |
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| Other Pre-specified | Fraction of Inspired Oxygen (FiO2) | Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods. Reported as median and inter-quartile range of all subjects. | Posted | Median | Inter-Quartile Range | fraction | 24 hours |
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| Other Pre-specified | Tidal Volume | The mean exhaled tidal volume of mechanical breaths. | Posted | Mean | Standard Deviation | ml/Kg | 24 hours |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Volume Guarantee Ventilation Period | This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation. These data represent the 24 hours of Volume Guarantee Ventilation. | 1 | 26 | 0 | 26 |
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