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| Name | Class |
|---|---|
| University Hospital, Motol | OTHER |
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The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted.
The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Target Range | No Intervention | The SpO2 TR width is set to 5% SpO2, as is routine in the department. The actual TR will vary depending on the GA, as is standard practice in the department. | |
| Narrow Target Range | Experimental | The SpO2 TR width is set narrower than the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department. |
|
| Shifted Target Range | Experimental | The SpO2 TR width is set as the Standard TR. The median of the TR is shifted up compared to the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrow TR | Device | The width of the PRICO SpO2 TR is set to 3% SpO2. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in the set SpO2 target range | Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance. | 30 days of intervention if possible |
| Percent time at SpO2 ≤80% and >98% | Percent time at SpO2 ≤80% and >98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded. | 30 days of intervention if possible |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time above the set SpO2 target range | Percent time above the set SpO2 target range. Periods with SpO2 higher than the target range with FiO2 = 0.21 will be excluded from time above the target range. | 30 days of intervention if possible |
| Percent time below the set SpO2 target range |
| Measure | Description | Time Frame |
|---|---|---|
| Associated effects | Effects associated with the mode of ventilation and set SpO2 control (based on gestational age) will be explored. The effects will be treated as covariables in a multivariate linear regression model with SpO2 target range compliance as a dependent variable. | 30 days of intervention if possible |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Orlova, MD | Motol University Hospital Prague, Neonatal Unit | Principal Investigator |
| Jan Janota, MD, PhD | Motol University Hospital Prague, Neonatal Unit | Principal Investigator |
| Thomas E Bachman, MSc | Czech Technical University in Prague | Principal Investigator |
| Jana Dornakova, MD | Motol University Hospital Prague, Neonatal Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motol University Hospital | Prague | 15500 | Czechia |
The IPD will be made available upon reasonable request in a deidentified, HIPAA-compliant form.
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice.
Once enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.
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| Shifted TR |
| Device |
The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2. |
|
Percent time below the set SpO2 target range. |
| 30 days of intervention if possible |
| Stability |
Effects associated with infant stability will be explored. The stability will be assessed based on the mean time in the SpO2 target range. |
| 30 days of intervention if possible |