Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system
研究概览
简要总结
The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.
Blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.
The infants will remain in the study as long as the Neosense measuring system is used
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:
- •The infant needs invasive measurement of blood pressure.
- •The infant needs repetitive sampling of blood.
- •The infant needs prolonged infusion(s) > 2 days.
- •The infant needs infusion of vessel irritating and potentially vessel harming solutions.
- •The infant is born extremely preterm (before 28+0 weeks gestational age).
- •A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).
- •The infant is undergoing therapeutic hypothermia following asphyxia ("oxygen deficiency at birth").
- •The infant has a severe infection/sepsis.
- •Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).
排除标准
- •Gastroschisis
- •Omphalocele
- •Peritonitis
- •Necrotizing enterocolitis
- •Omphalitis
- •The infant has a severe infection/sepsis
- •Expected MRI investigation within the 7 first days after birth
- •The infants birth weight is below 750 g
- •The infant is born before week 25+0
- •Local vascular compromise in lower limbs or buttocks area, or portal venous hypertension
结局指标
主要结局
Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system
时间窗: Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 8 days)
The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser.
次要结局
- Any deviations from normal procedures when inserting an umbilical catheter(During day 1)
- Number of monitor lock up or battery depletions(During study, in average 4-5 days)
- Adverse device effects of the Neosense monitor.(During study, in average 4-5 days)
- Any deviations from normal procedures when inserting an umbilical catheter.(During day 1)
- Clinical complications with the Neosense catheter.(Time Frame: During study, up to 8 days)