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临床试验/NCT03824249
NCT03824249已完成不适用

Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Resting energy expenditure (REE)

研究概览

简要总结

Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. For this reason, actual measurement of resting energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better approach.

Currently, IC is not validated during the use of non-invasive ventilation.

Aim of the present study is to validate the measurement of REE with IC in pediatric patients undergoing non-invasive ventilation through a single-limb circuit with intentional leak.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children admitted to the Pediatric Intensive Care Unit who completed the weaning phase from non-invasive ventilation.
  • age ≤ 6 years
  • patients whose parents provided signed informed consent

排除标准

  • age > 6 years
  • patients whose parents didn't provide signed informed consent

结局指标

主要结局

Resting energy expenditure (REE)

时间窗: 1 day

Resting energy expenditure expressed in kcal/kg/die

次要结局

  • Respiratory quotient (RQ)(1 day)
  • Carbon dioxide production (VCO2)(1 day)
  • Oxygen consumption (VO2)(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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