Randomised Cross-over Study of Servo-controlled Oxygen Targeting for Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Incidence of hyperoxia and hypoxia on transcutaneous monitoring
研究概览
简要总结
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.
Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.
Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen.
The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted manually or automatically.
详细描述
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or servo-control systems have been developed that result in tighter control of SpO2 and more time spent in the intended target range. These systems are already in clinical use. Automated systems produce quite large fluctuations in fraction of inspired oxygen (FiO2) in order to keep SpO2 in range. It is possible that this could result in short periods of high or low oxygen tension (PO2) that are undetectable using saturation monitoring. Studies to date have examined the effects of manual and automated (servo) oxygen targeting on SpO2 but not on transcutaneous oxygen tension (TcPO2).
There is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of manual and automated control as a first step in planning trials comparing these approaches over many weeks. When this is measured over a small number of hours it is not anticipated that this would have an influence on clinical outcome.
This study is a prospective, single centre, randomised crossover trial of automated (servo) control versus manual oxygen titration. Each infant will act as their own control. Infants born at less than 29 weeks gestation, greater than 48 hour of age and receiving supplementary oxygen will be eligible for inclusion.
The study will be undertaken in the Neonatal Unit at the Simpson Centre for Reproductive Health at the Royal Infirmary of Edinburgh.
Total study time is 12 hours for each infant. Infants will be randomised to commence on either automated (servo) control or manual mode. SpO2 (range 90-95%) will be continuously monitored as per normal standard of care. A second pulse oximetry probe will be place for servo control input.
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
盲法说明
The study is randomised but not blinded. Infants will be randomised to commence on either automated (servo) control or manual mode, and then cross-over to the alternative range after 6 hours of monitoring (total study time of 12 hours). SpO2 (range 90-95%) will be continuously monitored as per normal standard of care.
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at less than 29 weeks gestation
- •Infants greater than 48 hours of age
- •Infants who are receiving supplementary oxygen
- •Person with parental responsibility able to give consent
排除标准
- •Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
- •Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
结局指标
主要结局
Incidence of hyperoxia and hypoxia on transcutaneous monitoring
时间窗: 12 hours
To discover the percentage time spent within a TcPO2 range of 50mmHg (6.7kPa) - 80mmHg (10.7kPa) when infants are targeted to an SpO2 range of 90-95% using automated (servo) versus manual control.
次要结局
- Saturation variability(12 hours)
- Transcutaneous oxygen variability(12 hours)
- Pooled frequency histogram of FiO2(12 hours)
- Incidence of hyperoxia and hypoxia on saturation monitoring(12 hours)
- Fraction of inspired oxygen variability(12 hours)
- Pooled frequency histogram of TcPO2(12 hours)
- Pooled frequency histogram of SpO2(12 hours)
- Desaturations(12 hours)