Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter for Energy Expenditure Measurement in ICU Patients: The ICALIC International Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 7
- 主要终点
- Time needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters
研究概览
简要总结
This study will evaluate the ease of use of the new calorimeter (Q-NRG (COSMED, Italy)) in intensive care unit (ICU) patients compared to currently used calorimeters (i.e. Quark RMR 1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as the stability and the feasibility of the measurements in various clinically relevant situations.
Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as the measure of the ease of use of the calorimeter.
详细描述
Background and Aims:
This study aims at evaluating the ease of use of the new calorimeter for the measurement of energy expenditure (EE) in intensive care unit (ICU) patients. EE in ICU patients is highly variable depending on the severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support for the better clinical outcome. However, indirect calorimeters available on the market have insufficient accuracy for clinical and research use. Difficulties of handling and interpretation of results often limit IC in ICU patients. An accurate, easy-to-use calorimeter has been developed to meet these needs.
The Study Device:
The new calorimeter (Q-NRG, COSMED) is capable of IC measurements in mechanically ventilated patients without warm-up and limited calibration. The disposable in-line pneumotach flow meter and direct sampling of respiratory gas from the ventilator circuit enables the accurate measurement of oxygen consumption volume (VO2) and CO2 production volume (VCO2) to derive the energy expenditure. The software interface to manage the device and the collected data provides easy-to-use, user-friendly interface. Q-NRG does not bear the European Commission Conformity Mark (CE Mark), but has been approved by the Swiss authority for medical devices (Swissmedic) for use in this study. Q-NRG will be used in the way it is intended to be used as described in the instruction manual.
Currently used indirect calorimeters at each study center will be used as the comparator.
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
- •Mechanically ventilated adult ICU patients
排除标准
- •Fraction of inhaled oxygen (FIO2) > 70%
- •Positive end expiratory pressure (PEEP) >10cmH2O
- •Peak ventilatory pressure > 30cmH2O
- •Presence of air leaks from thoracic drain tube
- •Changes in vasoactive agent dose (>20%, <1 hr before and/or during IC)
- •Agitation or change in sedative dose (>20%, <1 hr before and/or during IC)
- •Change in body temperature (>0.5°C, <1 hr before and/or during IC)
- •Expected duration of ICU stay < 24 hours
- •Expected survival of the patient < 24 hours
结局指标
主要结局
Time needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters
时间窗: immediately after the measurement
Time from the start-up of the devices until the 1st recorded measurement will be measured and compared between Q-NRG and the currently used indirect calorimeters, including time needed for patient information input, warm-up and calibrations according to the instructions for the devices, and installation of the device components needed for the measurements on patients.
次要结局
- Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters(immediately after the measurement)
- CV of EE when measured in different levels of patient severity(immediately after the measurement)
- Coefficient of variation (CV) of EE for different mechanical ventilators(immediately after the measurement)
- CV of EE when using different ventilation modes(immediately after the measurement)
- CV of EE in various ranges of oxygen and airway pressure support(immediately after the measurement)
- CV of EE when measured in different sedation/consciousness levels(immediately after the measurement)
研究者
Prof. Claude Pichard
Claude Pichard, MD, PhD
University Hospital, Geneva