Indirect Calorimetry Measurement in the Paediatric Intensive Care Unit's Smallest Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Feasibility of Q-NRG+ indirect calorimetry measurements
研究概览
简要总结
Indirect calorimetry is considered the reference method for measuring energy expenditure in intensive care patients. However, in infants and small children weighing less than 10 kilograms, its clinical use has historically been limited due to technical challenges related to low tidal volumes, potential increases in dead space, and measurement precision.
The goal of this observational study is to evaluate the feasibility and performance of indirect calorimetry using the Q-NRG+ device in critically ill children weighing less than 10 kg who are admitted to a pediatric intensive care unit.
详细描述
Indirect calorimetry measures oxygen consumption and carbon dioxide production to calculate resting energy expenditure and is considered the reference method in intensive care. In mechanically ventilated pediatric patients, resting energy expenditure is commonly used as a surrogate for total energy expenditure, as activity-related expenditure is minimal due to sedation and ventilation. Despite its clinical relevance, the use of indirect calorimetry in children weighing less than 10 kg has been limited by technical challenges related to low tidal volumes and measurement precision. The Q-NRG+ is an indirect calorimeter designed to measure resting energy expenditure in mechanically ventilated and spontaneously breathing patients.
This prospective, single-center observational study will be conducted in a pediatric intensive care unit. Critically ill children weighing less than 10 kg who require mechanical ventilation or are spontaneously breathing and able to tolerate indirect calorimetry measurement using a canopy hood will be eligible for inclusion. Indirect calorimetry measurements will be performed according to a predefined protocol during the course of critical illness. For the measurement, a sampling module will be connected to the ventilator circuit without increasing ventilator dead space. The system continuously samples inspired and expired gases, and energy expenditure is calculated based on measured oxygen consumption and carbon dioxide production in combination with ventilator parameters.
The primary objective is to evaluate the feasibility of indirect calorimetry using the Q-NRG+ in critically ill children weighing less than 10 kg, defined as the proportion of technically valid and clinically interpretable measurements. Secondary objectives are to describe measured resting energy expenditure (kcal/kg/day) in this population, to evaluate changes in measured energy expenditure over the course of critical illness, and to compare measured energy expenditure with predicted energy requirements calculated using standard predictive equations. Demographic and clinical variables relevant to metabolic status (age, weight, diagnosis, ventilator settings, sedation, and phase of illness) will be collected from medical records. Descriptive and comparative statistical analyses will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns and infants admitted to the PICU with body weight from 0,5 up to 10 kilograms. Either requiring mechanically ventilation, with FiO2 < 70%, PIP<30 cmH2O and no leakage in the ventilation system. Or spontaneous breathing patients tolerating measurements with canopy.
排除标准
- •In mechanically ventilated patients' unstable ventilation including ventilation settings changed during the last 60 minutes (FiO2 >70%, PIP>30 cmH2O, or ventilation system leakage). Patients spontaneous breathing not tolerating measurements with canopy.
研究组 & 干预措施
Critically ill children with weight under 10 kilograms undergoing indirect calorimetry
This cohort includes critically ill children weighing less than 10 kilograms who are admitted to a pediatric intensive care unit. Participants undergo indirect calorimetry measurements using the Q-NRG+ device in addition to standard clinical care. Measured energy expenditure is recorded and analyzed without altering routine treatment.
干预措施: Q-NRG+ (Device)
结局指标
主要结局
Feasibility of Q-NRG+ indirect calorimetry measurements
时间窗: From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)
Feasibility is defined as the proportion of attempted Q-NRG+ measurements in infants weighing 0.5-10 kg that result in technically valid and clinically interpretable data according to predefined quality criteria (i) variability \<10% over a 15-minute period with constant Vt/MV (tidal volume/minute ventilation) and (ii) respiratory Quotient (RQ) within the range of \</=1 or \>/=0.7.
次要结局
- Agreement between carbon dioxide production measured by Q-NRG+ and volumetric capnography, Capnostat 5(During PICU stay (Day 1 to Day 7), when simultaneous Q-NRG+ and Capnostat 5 measurements are available (up to 5 measurements per patient).)
- Agreement between measured resting energy expenditure and predicted through Schofield equation.(During PICU stay, at each Q-NRG+ measurement (up to 5 measurements per patient).)
- Change in measured resting energy expenditure across phases of critical illness.(Daily during PICU stay, up to 5 Q-NRG+ measurements per patient.)
- Agreement between oxygen consumtion and carbondioxid production derived from blood gas respiratory quotient and Q-NRG+ measurements(Measurements will be collected from the time of first enrollment until the end of the study (Q2 2026 - Q4 2027).)
- Development of predictive model for resting energy expenditure in critically ill children under 10 kilograms.(During PICU stay, based on repeated Q-NRG+ measurements (up to 5 measurements per patient).)
研究者
Urban Fläring
Associated professor
Karolinska Institutet