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| Name | Class |
|---|---|
| Motol University Hospital | OTHER |
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The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.
There are 7 different averaging time settings available with PRICO (Acutronic Medical Systems AG, Hirzel, Switzerland), but after over a year of experience there is no clear clinical impression of the best setting. Therefore, a small systematic study is needed to determine the optimal guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Averaging time 4to6 s | Other | The SpO2 averaging time will be set to 4to6 s for the next 12 hours. All elements of care will be as routinely used, except the changing of the averaging time setting. |
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| Averaging time 10 s | Other | The SpO2 averaging time will be set to 10 s for the next 12 hours. All elements of care will be as routinely used, except the changing of the averaging time setting. |
|
| Averaging time 16 s | Other | The SpO2 averaging time will be set to 16 s for the next 12 hours. All elements of care will be as routinely used, except the changing of the averaging time setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 4to6 s | Device | The SpO2 averaging time will be set to 4to6 s for the next 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in SpO2 target range | Percent time in the intended SpO2 target range (compliance), at SpO2 <86% (safety), and at SpO2 >98% (safety). Period with SpO2 higher than the target range with FiO2 =0.21 will be included in the target range compliance and excluded from time above the target range. | 20 days of intervention on average |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of set SpO2 target range and mode of ventilation on the percent time in SpO2 target range, at SpO2 <86%, and at SpO2 >98%. | A general linear model will be used controlling for target range (based on gestational age), mode of ventilation (e.g. High-frequency oscillatory ventilation, Continuous mandatory ventilation, Continuous positive airway pressure, High-flow nasal cannula, and Nasal intermittent positive pressure ventilation), and subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Janota, PhD | Motol University Hospital | Principal Investigator |
| Thomas E Bachman, MSc | Czech Technical University in Prague | Principal Investigator |
| Veronika Rafl-Huttova, MSc | Czech Technical University in Prague | Principal Investigator |
| Jakub Rafl, PhD | Czech Technical University in Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motol University Hospital | Prague | 15500 | Czechia |
IPD will be available upon reasonable request
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Subjects will be switched between 3 averaging times (4to6s-10s-16s) every 12 hours. The sequence will be assigned in random order. Each enrolled subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2.
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| Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 10 s | Device | The SpO2 averaging time will be set to 10 s for the next 12 hours. |
|
| Fabian ventilator with PRICO system (Acutronic Medical Systems AG, Hirzel, Switzerland); SpO2 averaging time set to 16 s | Device | The SpO2 averaging time will be set to 16 s for the next 12 hours. |
|
| 20 days of intervention on average |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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