About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population consists of critically ill infants and children weighing 0.5-10 kg who are admitted to a pediatric intensive care unit and require mechanical ventilation or are spontaneously breathing and eligible for indirect calorimetry measurement. Participants are recruited consecutively during the study period (Q2 2026-Q4 2027).
Trial design
Cohort
Prospective
Treatments tested in this trial
Q-NRG+
DeviceThe Q-NRG+ is an indirect calorimetry device used to measure resting energy expenditure in mechanically ventilated or spontaneously breathing patients. In this study, the device is connected to the ventilator circuit or used with a canopy hood to measure oxygen consumption and carbon dioxide production for calculation of energy expenditure. Measurements are performed in addition to standard clinical care and do not alter routine treatment.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of Q-NRG+ indirect calorimetry measurements
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.
Secondary outcomes
Agreement between carbon dioxide production measured by Q-NRG+ and volumetric capnography, Capnostat 5
Comparison of carbon dioxide production measured using the Q-NRG+ device with obtained via other volumetric capnography already used in the clinic when available.
Agreement between measured resting energy expenditure and predicted through Schofield equation.
Comparison between resting energy expenditure measured by Q-NRG+ and estimated using the Schofield equation, commonly used in peadiatric intensive care units.
Change in measured resting energy expenditure across phases of critical illness.
Evaluation of variation in measured REE during acute, stable, and recovery phases of critical illness.
Agreement between oxygen consumtion and carbondioxid production derived from blood gas respiratory quotient and Q-NRG+ measurements
Comparison between oxygen consumtion and carbondioxid production calculated from blood gas central venous and arteriall and measured using Q-NRG+.
Other outcomes
Feasibility of canopy hood indirect calorimetry in non-intubated patients.
Assessment of rate of successful measurements and patient tolerance when using canopy hood indirect calorimetry in spontaneously breathing patients.
Sponsors and contacts
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