Accuracy of Capnography Monitoring in Invasively and Non-invasively Ventilated Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children without lung or heart disease
研究概览
简要总结
End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.
详细描述
End-tidal and arterial CO2 measurements will be performed in invasively and non-invasively ventilated critically ill children. The endtidal CO2 values will assessed for their accuracy with respect to different underlying diseases and conditions of the children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children on pressure controlled mechanical invasive or non-invasive ventilation on the Paediatric Intensive Care Unit of the University Children's Hospital Zurich
- •Newborns with a birthweight of at least 2.0 kg
- •Newborns with an age of at least 1 hour (age > 60 minutes)
- •Children up to the last day of the 13th year of living
- •Ability of care taker or patient to understand verbal and written instructions and the general consent or informed consent in German or English
- •Obtained written general or informed consent as documented by signature
- •Available arterial line, i.e. a specific catheter inserted in an artery
排除标准
- •Care taker or participant unable for linguistic, mental or other reasons or unwilling to understand verbal or written information and to give written informed consent in German or English
- •Care taker not available
- •Newborns with a birthweight below 2.0 kg
- •Newborns younger than 1 hour (age <60 minutes)
- •Children with an age of 14 years onwards
- •Missing arterial line
- •Patients dependent on any other kind of respiratory support that is not compatible with the PcCO2-sensor or where a high leakage in the respiratory circuit makes PcCO2 measurements impossible (nasal mask ventilation, low-flow-/high-flow-ventilation, rebreathing mask, high- frequency-oscillation)
- •Patients where the investigators act on the assumption that mechanical ventilation will be discontinued and/or the arterial line will be removed within 6 hours or where only one pair of values (arterial and endtidal CO2) can be compared
- •Patients with a cyanotic shunt lesion with a weight of 15 kg or above
结局指标
主要结局
Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children without lung or heart disease
时间窗: On average every participant will be assessed for 5 days
Mean absolute measurement difference between simultaneously obtained PaCO2 and PetCO2 values (bias) and their 95% limits of agreement (precision) in children and newborns without cardiopulmonary dysfunction. Units of measure will be in kilopascal (kPa) for PetCO2 and PaCO2, respectively.
次要结局
- Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children with lung and or heart disease(On average every participant will be assessed for 5 days)
研究者
Vincenzo Cannizzaro
Senior consultant and head of research
University Children's Hospital, Zurich