Ventilator Lung; Newborn Clinical Trial
— optimalSPOCOfficial title:
Automatic Oxygen Control (SPOC) in Preterm Infants - Evaluation of a Revised Algorithm and Effect of Averaging Time of Pulse Oximetry Signal
Single-center, randomised controlled, cross-over clinical trial in preterm infants born at
gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support
(continous positive airway pressure (CPAP) or non-invasive ventilation (NIV) or invasive
ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2)
will be tested against RMC supported by automatic control (SPOC) with "old"-algorithm and RMC
supported by CLAC with "new"-algorithm.
The first primary hypothesis is, that the use of the "new" algorithm results in more time
within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori
subordinate hypothesis is, that the new algorithm results in more time within SpO2 target
range compared to SPOCold.
The second primary hypothesis is, that the use of 2 seconds averaging time of the SpO2 Signal
results in more time within arterial oxygen saturation (SpO2) target range compared to the
use of 8 seconds averaging interval of the SpO2 signal.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 34 Weeks |
Eligibility |
Inclusion Criteria: - gestational age at birth <34+1/7weeks and - invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support and - Fraction of inspired oxygen above 0.21 before inclusion and - more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion and - parental written informed consent Exclusion Criteria (any of the following): - congenital pulmonary anomalies - congenital heart defects influencing SpO2 (i.e. cyanotic heart defects) - right-to -left shunt through a PDA - Severe neonatal complications during study period (sepsis, necrotising enterocolitis) - diaphragmatic hernia or other diaphragmatic disorders |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Neonatology, University Children's Hospital | Tübingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | Fritz Stephan GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Staff workload | number of manual adjustments of inspired oxygen per time | 30 hours | |
Other | Validation of clinical Apnea Score | Validation of a modified Apnea Score monitored by clinical staff by correlation between Score and other secondary outcomes. The modified Apnoea Score aims to quantify the burden from apnoea-bradycardia-syndrome by assigning 1-2-4 or 8 points according to event severity. Points are summed up during each treatment period in this study. | 30 hours | |
Primary | Proportion of time with SpO2 within target range | Comparison of proportion of time with SpO2 within target range and time above target range if no supplemental oxygen was administered at that time and within the preceding 30sec between the five treatment modalities | 30 hours | |
Secondary | Proportion of Time with SpO2 above target range | Comparison of proportion of time with SpO2 above target range if supplemental oxygen was administered at that time or within the preceding 30sec . | 30 hours | |
Secondary | Proportion of Time with SpO2 below target range | Comparison of proportion of time with SpO2 below target range. | 30 hours | |
Secondary | Proportion of Time with Hypoxia | Comparison of proportion of time with SpO2 below 80%. | 30 hours | |
Secondary | Proportion of Time with Hyperoxia | Comparison of proportion of time with SpO2 above 97% if supplemental oxygen was administered at that time or at anytime during the previous 30 seconds. | 30 hours | |
Secondary | Stability of cerebral oxygenation | "Area under the curve" of cerebral tissue saturation or fraction of tissue oxygen extraction outside of the infants Median +- 5% or outside of the "safe" interval of 55-80% rcStO2. | 30 hours | |
Secondary | Severe hypoxemic episodes | Rate of episodes with SpO2 <80% for at least 60seconds | 30 hours |
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