Development and Validation of a New Indirect Calorimetry Device for Energy Expenditure Measurement in ICU Patients: The ICALIC International Multicentric Study
试验速览
- 阶段
- 不适用
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- calories reference IC devices in intubated ICU patients on mechanical ventilation
研究概览
简要总结
Energy expenditure (EE) in critically ill patients is highly variable depending on the initial severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support. IC devices available on the market have insufficient accuracy for clinical and research use. A new IC is being developed to meet these needs.
Objectives: Validation of a reliable and easy-to-use IC device.
Primary objective:
• Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC devices in intubated ICU patients on mechanical ventilation
Secondary objectives:
- Accuracy of EE measurements in ICU patients of spontaneous breathing
- Accuracy of EE measurement during ~30 min. vs. the sum of 6 periods of 60 min/12 hrs
- Accuracy of EE measurements in ICU patients on non-invasive mechanical ventilation
Design: Prospective, controlled, observational multicenter study.
Subjects: 182 ICU patients.
详细描述
Energy expenditure (EE) in critically ill patients is highly variable depending on the initial severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support. IC devices available on the market have insufficient accuracy for clinical and research use. A new IC is being developed to meet these needs.
Objectives: Validation of a reliable and easy-to-use IC device.
Primary objective:
• Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC devices in intubated ICU patients on mechanical ventilation
Secondary objectives:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ICU patients with spontaneous breathing, or on invasive or non-invasive mechanical ventilation.
排除标准
- •FiO2 > 60%
- •Kidney failure requiring Continous veno-venous hemofiltration (CVVH)
- •Conditions promoting air leaks: Positive end-expiratory pressure (PEEP) >10, Peak ventilatory pressure > 30
- •Chest tube (except if only for liquid drainage = no bubbling)
- •Unstable hemodynamic conditions requiring changes in vasoactive drugs either 1 hour before and/or during the IC measurement (i.e. all conditions resulting in unstable pH during IC measurements).
- •Change in body temperature >0.5°C either 1 hr before and/or during the IC measurement
- •Physical agitation or curarization either 1 hour before and/or during the IC measurement
结局指标
主要结局
calories reference IC devices in intubated ICU patients on mechanical ventilation
时间窗: 30 minutes
Accuracy of EE measurements (kcal/d measured over 30 min) of the new and the reference IC devices in intubated ICU patients on mechanical ventilation
次要结局
- calories(30 minutes)
研究者
Prof. Claude Pichard
Professor of nutrition
University Hospital, Geneva