Randomised Cross-over Study of Closed Loop Oxygen Control in Newborn Infants Receiving Nasal Highflow Therapy Via Airvo-2 Combined With O2Matic
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- time in target SpO2 range 90%-95% (90%-100% if FiO2 =21%)
研究概览
简要总结
The main goal of this trial is to test if:
automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturation
results in more stable blood-oxygenation compared to routine nurse controlled adjustment of oxygen
详细描述
Due to immature lungs and immature regulation of breathing, preterm infants require long periods of respiratory support including supplemental oxygen. Noninvasive monitoring of oxygenation using pulse oximetry (SpO2, blood oxygen saturation) has become standard of care despite not always accurately reflecting paO2 (partial pressure of oxygen). Several clinical trials have aimed to determine the optimal range for SpO2. Although subject to an ongoing debate currently most neonatal units aim to keep SpO2 within a target-range (TR) of 90-95% based on consensus guidelines. Recent reviews and meta-analyses have shown that SpO2 outside this range is associated with adverse outcome. Hyperoxia is associated with BPD (bronchopulmonary dysplasia) and ROP (retinopathy of prematurity), whereas hypoxia is associated with an increased risk of necrotizing enterocolitis, death and brain damage.
Keeping SpO2 within TR is difficult for the clinical staff and may require frequent manual adjustments of FiO2 (fraction of inspired oxygen) thus representing a huge workload. Recent studies have shown that babies often spend less than 50% of time with SpO2 within target range.
Due to limitations of manual control of FiO2, several commercially available algorithms have been developed facilitating automatic oxygen control (AOC) or closed loop automated oxygen control (CLAC) using feedback from the pulse oximetry as input. Observational trials, randomized clinical trials as well as meta-analyses of short-term outcomes have with a reasonable consistency shown automatic oxygen control to be associated with a significant increase in SpO2 spent in TR from approximately 50% to above 70-80% of time, a reduction in number and duration of episodes with hypoxemia and hyperoxemia , and a substantial reduction in the need for manual adjustments of FiO2 from more than 20 times to one during automated oxygen control.. It still remains to be determined if automatic oxygen control improves relevant long term outcomes, but a large international multi-center randomized clinical trial (FiO2-C Trial) is expected to report on long-term outcomes within 12-24 months.
The current commercially available systems for automatic oxygen control are integrated into brand- specific ventilator-systems and may only work with devices and consumables from that particular company. O2matic® is a danish automatic oxygen control system registered for use in adult patients and has been shown to be significantly better than manual control to maintain SpO2 within target O2matic® has never been tested in a neonatal population but can potentially be used as an add-on to several respiratory support systems used in neonatal care, possibly making automatic oxygen control more universally available at a lower cost. This protocol describes a proposed pilot-trial of automatic oxygen control using O2matic® in spontaneously breathing newborn infants needing respiratory support.
Research question and aim The primary objective is to evaluate if automated adjustment of FiO2 by O2Matic during neonatal nasal highflow therapy or CPAP improves the duration of SpO2 being within target range when compared to nurse-controlled (manual) adjustment of FiO2.
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 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants receiving nHFT via Optiflow 4-8 l/min and FiO2>0.25, requiring adjustments of FiO2 beyond the extra need during care procedures
- •Likely to be maintained on nHFT during study period of 48 hrs
排除标准
- •major congenital abnormalities
- •hemodynamic instability including large PDA with right to left shunting
- •clinician's concern regarding infant stability.
- •Unstable infants with frequent apneas, predominantly having need for oxygen during apneic events
结局指标
主要结局
time in target SpO2 range 90%-95% (90%-100% if FiO2 =21%)
时间窗: 48 hours
total time spent in target SpO2 range: * measured by the Nonin pulse oximeter connected to O2Matic and/or * measured by the Avant 9600 Nonin Pulse oximeter providing data from this pulse oximeter
次要结局
- relative SpO2 distribution in the ranges <80%, 81-85%, 86-89%, 90-95%, >95%(48 hours)
- burden of hypoxia, i.e. the 'area under the curve' using spO2 = 80% as the threshold(48 hours)
- overall mean FiO2(48 hours)
- duration of episodes with SpO2 above 95% or below 90%(48 hours)
- number of episodes of SpO2 below 80% lasting at least 60 seconds(48 hours)
- overall mean flow(48 hours)
- frequency of episodes with SpO2 above 95% or below 90%(48 hours)
- frequency of FiO2 adjustments recorded by O2Matic both during automated and manual mode(48 hours)
- number of "manual override" of FiO2 control during automated mode(48 hours)
研究者
Christian Heiring
Principal Investigator
Rigshospitalet, Denmark