Methods A prospective observational study was performed in the NICU of the LUMC, which is a tertiary level perinatal center in the Netherlands with an average of 650 intensive care admissions per year. In the Netherlands, no ethical approval is required for anonymised studies with medical charts and patient data that were collected and noted for standard care. The LUMC Medical Ethics Committee provided a statement of no objection for obtaining and publishing the anonymised data. All preterm infants <30 weeks of gestation (GA) admitted to the NICU before and after the implementation of the automated FiO2 control in August 2015 (May 2015 - January 2016) receiving respiratory support (endotracheal and non-invasive ventilation) using the AVEA ventilator (CareFusion, Yorba Linda California) were included. Preterm infants with major congenital heart disease were excluded. The characteristics, of each infant as well as clinical parameters and ventilator settings (including FiO2 and SpO2) were sampled every minute and routinely collected in the patient data management system (PDMS) (Metavision; IMDsoft, Tel Aviv, Israel). During both periods the heart rate and SpO2 was collected using a neonatal pulse oximeter (Masimo Radical, Masimo Corporation, Irvine CA, USA) with an averaging time set at 8 seconds, integrated into the AVEA ventilator. Data was collected when infants received respiratory support by the AVEA and only included for analysis when supplemental oxygen was given, until the infants reached a gestational age of 32 weeks. After 32 weeks most infants are transferred out of the intensive care area in our unit or to a regional hospital, where no automated FiO2 control is available. During the manual and the automated FiO2 control periods, SpO2 was measured using a neonatal pulse oximeter integrated into the AVEA ventilator. During the manual period the nurses manually titrated the supplemental oxygen following local guidelines. During the automated period, an automated FiO2 control device integrated in the ventilator was used (CLiO2), in addition to manual adjustments. The CLiO2 function is a Closed-Loop controller designed to regulate FiO2 levels for preterm infants receiving support and oxygen from a mechanical ventilator. The FiO2 is
Methods A prospective observational study was performed in the NICU of the LUMC, which is a tertiary level perinatal center in the Netherlands with an average of 650 intensive care admissions per year. In the Netherlands, no ethical approval is required for anonymised studies with medical charts and patient data that were collected and noted for standard care. The LUMC Medical Ethics Committee provided a statement of no objection for obtaining and publishing the anonymised data. All preterm infants <30 weeks of gestation (GA) admitted to the NICU before and after the implementation of the automated FiO2 control in August 2015 (May 2015 - January 2016) receiving respiratory support (endotracheal and non-invasive ventilation) using the AVEA ventilator (CareFusion, Yorba Linda California) were included. Preterm infants with major congenital heart disease were excluded. The characteristics, of each infant as well as clinical parameters and ventilator settings (including FiO2 and SpO2) were sampled every minute and routinely collected in the patient data management system (PDMS) (Metavision; IMDsoft, Tel Aviv, Israel). During both periods the heart rate and SpO2 was collected using a neonatal pulse oximeter (Masimo Radical, Masimo Corporation, Irvine CA, USA) with an averaging time set at 8 seconds, integrated into the AVEA ventilator. Data was collected when infants received respiratory support by the AVEA and only included for analysis when supplemental oxygen was given, until the infants reached a gestational age of 32 weeks. After 32 weeks most infants are transferred out of the intensive care area in our unit or to a regional hospital, where no automated FiO2 control is available. During the manual and the automated FiO2 control periods, SpO2 was measured using a neonatal pulse oximeter integrated into the AVEA ventilator. During the manual period the nurses manually titrated the supplemental oxygen following local guidelines. During the automated period, an automated FiO2 control device integrated in the ventilator was used (CLiO2), in addition to manual adjustments. The CLiO2 function is a Closed-Loop controller designed to regulate FiO2 levels for preterm infants receiving support and oxygen from a mechanical ventilator. The FiO2 is
17_1_2017_The_effect_of_implementing_an_automated_oxygen_control_on_oxygen_saturation_in_preterm_infants.docx