Agreement of Transcutaneous Partial Oxygen and Carbon Dioxide Pressure With Arterial and Capillary Blood Gas Values. A Single Centre Prospective Non-randomized Trial in Critically Ill Neonates.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Bias and precision of the transcutaneous oxygen and carbon dioxide measurements
研究概览
简要总结
Partial blood oxygen and carbon dioxide pressures obtained in critical ill neonates by transcutaneous sensors will be compared to respective values obtained by medically indicated arterial and capillary blood gas analyses. The influence of blood withdrawal method, sensor operational temperature and application time, presence of cyanotic heart malformations and/or intra or extra cardiac right to left shunt, vasoactive drugs, elevated non-conjugated bilirubin, and skin and soft tissue oedema, skin colour and perfusion conditions will be elucidated as well as sensor's safety. Study duration will be 48 hours with sensors applied and additional 4 hours of further surveillance for thermal injury.
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
- 年龄范围
- — 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Late premature or term birth newborn infants (34 0/7 until 43 6/7 weeks gestational age (GA)).
- •Age between first day of life and 43 6/7 weeks postmenstrual age.
- •Ability of care taker to understand verbal and written instructions and informed consent in German.
排除标准
- •Care taker unable or unwilling to give written informed consent in German.
- •Care taker not understanding German and without a family member able to translate.
- •Written informed consent cannot be obtained for any other reason.
研究组 & 干预措施
All included patients
All included patients will undergo the intervention of transcutaneous sensor placement
干预措施: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor (Device)
结局指标
主要结局
Bias and precision of the transcutaneous oxygen and carbon dioxide measurements
时间窗: 52 hours
Agreement of transcutaneous measurements with capillary and arterial blood gas values at two operational sensor temperatures (42 and 43°C).
次要结局
- Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin(52 hours)
- Agreement of partial transcutaneous oxygen and carbon dioxide pressures with arterial and capillary values in children with echocardiographically determined congenital cyanotic heart disease and/or intra or extra cardiac right to left shunt(52 hours)
- Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone)(52 hours)
- Bias and precision of the oxygen and carbon dioxide transcutaneous measurements over time at one anatomical site with determination of technical drift and physiological drift(52 hours)
- Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion(52 hours)
- Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types(52 hours)
- Safety of OxiVenT sensor: Appearance of signs of thermal injury (redness, blisters, necrosis) under application of transcutaneous sensor temperatures of 42 and 43°C(52 hours)
- Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema(52 hours)
研究者
Vera Bernet, MD
Senior Consultant Pediatric Intensive Care
University Children's Hospital, Zurich