The ICALIC 2 International Multicentric Study (ICALIC2)
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|ClinicalTrials.gov Identifier: NCT03947294|
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment|
|Cancer Surgery Hemodialysis||Device: Q-NRG®|
This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.
Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.
In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.
|Study Type :||Observational|
|Estimated Enrollment :||720 participants|
|Official Title:||Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter in Canopy and Face Mask Modes for Energy Expenditure Measurement: The ICALIC 2 International Multicentric Study (Second Phase)|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||November 6, 2020|
|Estimated Study Completion Date :||May 31, 2021|
- Device: Q-NRG®
Energy expenditure measurementsOther Name: Currently used calorimeters
- Time needed to perform EE measurement. [ Time Frame: Immediately after the measurement ]Time needed to perform EE will be calculated from the time the Q-NRG® or the currently used calorimeter is turned on to EE measurement reaches a steady state with a variation ≤10%.
- Accuracy and precision of VO2, VCO2, RQ and EE measurements. [ Time Frame: Immediately after the measurement. ]Accuracy and precision of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.
- Coefficient of variation of VO2, VCO2, RQ and EE. [ Time Frame: Immediately after the measurement. ]The stability of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.
- Clinical condition restriction. [ Time Frame: Immediately after the measurement. ]Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRG®.
- Accuracy of O2 and CO2 analysis. [ Time Frame: Immediately after the measurement. ]Accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® assessed by comparison with a mass spectrometer.
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): NCT03947294
|Contact: Claude Pichardfirstname.lastname@example.org|
|Contact: Yves M Dupertuisemail@example.com|
|Geneva University Hospital||Recruiting|
|Geneva, Geneva 14, Switzerland, 1211|
|Contact: Claude Pichard +41223729345 firstname.lastname@example.org|
|Contact: Yves M Dupertuis +41223723389 email@example.com|