Automatic Oxygen Control (SPOC) in Preterm Infants - Evaluation of a Revised Algorithm and Effect of Averaging Time of Pulse Oximetry Signal
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Proportion of time with SpO2 within target range
研究概览
简要总结
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.
详细描述
BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigators developed a system for closed-loop automatic control (SPOC) of the FiO2. The objective of this study is to test a revised, "new" algorithm with 3 adaptions against the former "old" algorithm and against RMC. The 3 adaptions are:
- Faster re-adjustment to baseline-FiO2 (baseline FiO2: mean FiO2 during the previous 5min)
- Delayed reduction of FiO2 below baseline FiO2
- Maximum FiO2 adjustable by user
The first primary hypothesis is, that the application of SPOCnew in addition to RMC results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the revised algorithm is more effective as the old algorithm to maintain the SpO2 in the target range.
The second primary hypothesis is, that the shortening of averaging time used for the SpO2 Signal from 8 seconds to 2 seconds results in more time within SpO2 target range for both, SPOCnew and SPOCold.
Further hypotheses for exploratory testing are, that the SPOC new algorithm will achieve a lower proportion of time with SpO2 above and below the target range, hyper- and hypoxia and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with SPOCold and RMC. Reduction of staff workload (estimated by number of manual adjustments per hour) by SPOC. Validation of a clinical scoring tool to monitor severity of apnea of prematurity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
RMC only
routine manual control (RMC) of the fraction of inspired oxygen (FIO2)
SPOCnew and 2s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 2s.
干预措施: SPOCnew (Device)
SPOCnew and 2s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 2s.
干预措施: 2s SpO2 averaging (Device)
SPOCnew and 8s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 8s.
干预措施: SPOCnew (Device)
SPOCnew and 8s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 8s.
干预措施: 8s SpO2 averaging (Device)
SPOCold and 2s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 2s.
干预措施: SPOCold (Device)
SPOCold and 2s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 2s.
干预措施: 2s SpO2 averaging (Device)
SPOCold and 8s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 8s.
干预措施: 8s SpO2 averaging (Device)
SPOCold and 8s SpO2 averaging
routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 8s.
干预措施: SPOCold (Device)
结局指标
主要结局
Proportion of time with SpO2 within target range
时间窗: 30 hours
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
次要结局
- Proportion of Time with Hypoxia(30 hours)
- Proportion of Time with SpO2 above target range(30 hours)
- Proportion of Time with SpO2 below target range(30 hours)
- Proportion of Time with Hyperoxia(30 hours)
- Stability of cerebral oxygenation(30 hours)
- Severe hypoxemic episodes(30 hours)