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No participation of centers outside Switzerland because of difficulty in recruiting during a Covid pandemic.
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Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.
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-NRGĀ® 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 ā¤10%.
In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRGĀ® will be assessed by comparison with the reference method consisting in a mass spectrometer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q-NRGĀ® | Device | Energy expenditure measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time needed to perform EE measurement. | Time needed to perform EE will be calculated from the time the Q-NRGĀ® or the currently used calorimeter is turned on to EE measurement reaches a steady state with a variation ā¤10%. | Immediately after the measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy and precision of VO2, VCO2, RQ and EE measurements. | Accuracy and precision of VO2, VCO2, RQ and EE measurements with the Q-NRGĀ® in face mask or canopy mode will be compared to currently used indirect calorimeters. | Immediately after the measurement. |
| Coefficient of variation of VO2, VCO2, RQ and EE. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of O2 and CO2 analysis. | Accuracy of gas composition (O2 and CO2) measurement by the Q-NRGĀ® assessed by comparison with a mass spectrometer. | Immediately after the measurement. |
Inclusion Criteria:
All spontaneously breathing adult patients (ā„ 18 years) referred to the Nutrition Unit in the context of malnutrition, cancer, surgery or haemodialysis.
Exclusion Criteria:
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Spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospital | Geneva | Geneva 14 | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35671611 | Derived | Dupertuis YM, Delsoglio M, Hamilton-James K, Berger MM, Pichard C, Collet TH, Genton L. Clinical evaluation of the new indirect calorimeter in canopy and face mask mode for energy expenditure measurement in spontaneously breathing patients. Clin Nutr. 2022 Jul;41(7):1591-1599. doi: 10.1016/j.clnu.2022.05.018. Epub 2022 May 27. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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The stability of VO2, VCO2, RQ and EE measurements with the Q-NRGĀ® in face mask or canopy mode will be compared to currently used indirect calorimeters. |
| Immediately after the measurement. |
| Clinical condition restriction. | Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRGĀ®. | Immediately after the measurement. |