The ICALIC International Multicentric Study (ICALIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02796430|
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : September 12, 2017
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.
|Condition or disease||Intervention/treatment|
|Critical Illness||Other: Time needed to start indirect calorimetry measurement Other: Indirect calorimetry measurement|
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.
|Study Type :||Observational|
|Estimated Enrollment :||343 participants|
|Official Title:||Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter for Energy Expenditure Measurement in ICU Patients: The ICALIC International Multicentric Study|
|Actual Study Start Date :||September 10, 2017|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Mechanically ventilated patients
Ease of use will be assessed by analysing the time needed to start indirect calorimetry measurement, and results of indirect calorimetry measurements by both the new indirect calorimeter and the currently used calorimeters at each study center.
Other: Time needed to start indirect calorimetry measurement
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.
Other: Indirect calorimetry measurement
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 needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters [ 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.
- Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters [ 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.
- Coefficient of variation (CV) of EE for different mechanical ventilators [ 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.
- CV of EE when using different ventilation modes [ 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.
- CV of EE in various ranges of oxygen and airway pressure support [ 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.
- CV of EE when measured in different sedation/consciousness levels [ 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.
- CV of EE when measured in different levels of patient severity [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796430
|Contact: Taku Oshima, MD, PhDfirstname.lastname@example.org|
|Contact: Claude Pichard, MD, PhD||+41223729345||Claude.Pichard@hcuge.ch|
|Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine||Not yet recruiting|
|Contact: Michael Hiesmayr, MD email@example.com|
|Department of Intensive Care, Vrije Universiteit Brussel||Not yet recruiting|
|Contact: Elisabeth DeWaele, MD, PhD Elisabeth.DeWaele@uzbrussel.be|
|Critical Care Medicine, Institute for Nutrition Research, Rabin Medical Center, Beilison Hospital||Not yet recruiting|
|Petah Tikva, Israel, 49100|
|Contact: Pierre Singer, MD firstname.lastname@example.org|
|Department of Anaesthesiology and Intensive Care Haukeland University Hospital||Not yet recruiting|
|Bergen, Norway, 5021|
|Contact: Anne Berit Guttormsen, MD, PhD email@example.com|
|Department of Anesthesiology and Intensive Care Medicine, Karolinska University Hospital||Not yet recruiting|
|Contact: Jan Wernerman, MD,PhD firstname.lastname@example.org|
|Service of Intensive Care, Geneva University Hospital||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Claudia-Paula Heidegger, MD email@example.com|
|Contact: Severine Graf Severine.Graf@hcuge.ch|
|Adult Intensive care, Lausanne University Hospital||Not yet recruiting|
|Lausanne, Switzerland, 1011|
|Contact: Mette M Berger, MD, PhD Mette.Berger@chuv.ch|
|Principal Investigator:||Claude Pichard, MD, PhD||Clinical Nutrition, Geneva University Hospital|