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临床试验/NCT07468006
NCT07468006招募中不适用

Comparison of Transcutaneous Carbon Dioxide Monitoring With Arterialized or Arterial Blood Gas Analysis in PICU

Brno University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Partial CO2 difference

研究概览

简要总结

Transcutaneous capnometry (tPCO₂) is a non-invasive method for continuous monitoring of ventilation status. In pediatric intensive care patients, it may reduce the need for repeated arterial or arterialized blood sampling. However, the accuracy of tPCO₂ may be influenced by factors such as peripheral perfusion, skin temperature, and vasopressor therapy. This prospective observational study compares transcutaneous carbon dioxide measurements with arterialized or arterial blood gas PaCO₂ values in children with respiratory insufficiency, including a subgroup receiving vasopressor support.

详细描述

This prospective observational study will be conducted in a pediatric intensive care unit to assess agreement between transcutaneous carbon dioxide monitoring and arterialized or arterial blood gas analysis. Consecutive pediatric patients aged 1-18 years with respiratory insufficiency or impaired peripheral perfusion requiring vasopressor support will be included if repeated blood gas sampling is clinically indicated.

Paired measurements of tPCO₂ and PaCO₂ will be analyzed using Bland-Altman methods with correction for repeated measures. Subgroup analyses will evaluate the influence of vasopressor therapy on measurement accuracy. Secondary analyses will compare tPO₂ and PaO₂ values. The study aims to define the clinical applicability and limitations of transcutaneous capnometry in critically ill pediatric patients.

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 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 1-18 years
  • Diagnosis of respiratory insufficiency or impaired peripheral perfusion
  • Expected need for more than one arterialized capillary or arterial blood gas sample
  • Admission to PICU

排除标准

  • Repeated failure of sensor adhesion
  • Hypothermia < 35 °C
  • Time difference > ±5 minutes between tPCO₂ and blood sampling
  • Large tPCO₂ variability (> ±1 kPa) in 15 minutes preceding blood sampling
  • Non-physiological tPCO₂ values incompatible with life

结局指标

主要结局

Partial CO2 difference

时间窗: periprocedural

Agreement between transcutaneous CO₂ (tPCO₂) and arterialized or arterial PaCO₂ assessed using Bland-Altman analysis (bias, SD, 95% limits of agreement).

次要结局

  • Vassopressor use(periprocedural)
  • Proportion of pCO2(periprocedural)
  • Partial O2(periprocedural)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Petr Štourač, MD

prof. Petr Štourač, MD, PhD, MBA, LLM, FESAIC

Brno University Hospital

研究点 (1)

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