Crossover Study of the Work of Breathing at Different Levels of BiPAP Settings in Neonates
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Work of breathing
研究概览
简要总结
Some infants with breathing problems at birth may need to be connected to a machine to help support their breathing. The purpose of this study is to optimise the level of breathing support on Bi level continuous airway pressure (BiPAP), a support which gives two levels of support (pressure) to premature infants.
The study is investigating which upper pressure gives the best support, that is results in the baby having to breathe less hard (work of breathing).
Researchers will measure the work of breathing using a small catheter. Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each. In between each upper level they will receive the standard upper pressure for 20 minutes.
详细描述
Bilevel continuous positive airway pressure (BiPAP) is a type of non-invasive respiratory support which can be used as breathing support in neonates requiring some pressure support to help their breathing. BiPAP provides cycles of higher and lower pressure levels at set intervals, usually with a baseline pressure constant of 5cm H2O.
In the UK, other forms of non-invasive ventilation, such as NIPPV and NIV-NAVA, have been shown to be efficacious, however they are expensive. BiPAP may therefore provide a viable and cost-effective alternative. Currently there are no written guidelines about BiPAP use.
The investigators aim to identify the most efficacious BiPAP settings for preterm infants as primary support and post-extubation as well as in those with evolving BPD. Infants will be studied at three different upper pressure settings for a period of 20 minutes each. The work of breathing will be measured from small pressure transducers situated on a thin catheter, the size of a feeding tube. The catheter will be passed through the mouth and positioned so the tip is in the stomach. Simultaneous measurements for work of breathing using transcutaneous diaphragm electromyography will also be taken. Following the study the infant will subsequently be nursed on the breathing support type associated with the lower work of breathing.
The investigators aim to recruit 21 patients, with 7 in each arm of the trial. Sample size was derived using previous study results in which the SD of the PTPdi was 78cmH2Os/min in 40 preterm infants of 28-34 weeks gestation and a clinically significant difference of 133cmH2Os/min was observed between infants on SNIPPV against high flow NIV support. To detect such a difference with 90% power and 5% significance, 7 infants would be required in each group, that is 21 infants in total in 3 groups.
The parents of potential participants will be approached by the clinical team initially, subsequently the research fellow will provide them with the study information. Responsibility for recording and dating oral, electronic, and written informed consent or advice will be with the researchers identified in the formal delegation log.
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
- Double (Participant, Outcomes Assessor)
盲法说明
During the study the infant and their parents will not be aware of which pressures they are on. Due to the nature of the study it is not possible to blind the care provider who in this case is the investigator since they need to manipulate the ventilator settings. However, data analysis with be done using anonymous data and the investigator will be blinded to which pressure settings were used.
入排标准
- 年龄范围
- 2 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born <34 weeks of gestation at KCH requiring primary respiratory support before intubation, after extubation or requiring respiratory support after seven days
- •Infants aged between 2 days and 2 months at time of study
排除标准
- •Infants with congenital abnormalities of the respiratory system.
- •Infants with blood-culture confirmed sepsis.
- •Recent gastrointestinal surgery (within 7 days)
- •Non-English speakers
结局指标
主要结局
Work of breathing
时间窗: Over the last 5 minutes of the 20 minute study period on each setting of BiPAP
Oesophageal (Poes) and gastric pressures(Pgas) will be measured using a catheter with dual pressure tipped transducers (Gaeltec, Dunvegan, Scotland, UK). Transdiaphragmatic pressure (PTPdi) will be calculated by digital subtraction of the oesophageal from the gastric pressure and tidal volume obtained by digital integration of the flow signal by the acquisition software. The mean PTPdi will be calculated from 20 consecutive breaths to measure work of breathing.
次要结局
未报告次要终点