NCT Number: NCT02796430
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.
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All sexes
Observational
Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine, Vienna, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of the time needed to start EE measurements by the new calorimeter and the currently used calorimeter, including the time needed for calibration, patient data input, connection to the ventilator circuit.
Comparison of EE measurements by the new calorimeter and the currently used calorimeter when using different mechanical ventilators, different ventilation modes, different patient conditions and severity
Time frame: 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.
Time frame: immediately after the measurement
EE measured by Q-NRG and currently used calorimeters will be compared to identify the differences of the characteristics of the measurements according to the different types of calorimeters.
Time frame: immediately after the measurement
CV of EE measured by Q-NRG when using different mechanical ventilators will be analyzed to evaluate the effects of the mechanical ventilators used during the indirect calorimetry measurement.
Time frame: immediately after the measurement
CV of EE measured by Q-NRG when using different mechanical ventilation modes will be analyzed to evaluate the effect of different mechanical ventilation modes used during the indirect calorimetry measurement.
Time frame: immediately after the measurement
CV of EE measured by the Q-NRG in different ranges of FiO2 will be analyzed to evaluate the difference in the stability of the measurements according to various FiO2 ranges.
Time frame: immediately after the measurement
CV of EE measured by the Q-NRG in different levels of sedation/consciouness will be analyzed to evaluate the difference in the stability of the measurements according to various sedation/consciousness levels.
Time frame: immediately after the measurement
CV of EE measured by the Q-NRG in different levels of patient severity will be analyzed to evaluate the difference in the stability of the measurement according to various levels of severity.
University Hospital, Geneva
Other
Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter for Energy Expenditure Measurement in ICU Patients: The ICALIC International Multicentric Study
Acronym: ICALIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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