The ICALIC 2 International Multicentric Study

Cancer Clinical Trial

— ICALIC2  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03947294
• Other study ID #: 2019-00106
• Status: Terminated
• Start date: May 7, 2019
• Est. completion date: June 2, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All spontaneously breathing adult patients (= 18 years) referred to the Nutrition Unit in the context of malnutrition, cancer, surgery or haemodialysis.

Exclusion Criteria:

1. < 18 years

2. Intolerance or phobia to canopy or face mask

3. Physical agitation or activity (< 1hr before EE measurement)

4. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Related Conditions & MeSH terms

• Cancer
• Hemodialysis
• Surgery

Intervention

Device:
• Q-NRG®
Energy expenditure measurements

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva	Geneva 14

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Claude Pichard

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of O2 and CO2 analysis.	Accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® assessed by comparison with a mass spectrometer.	Immediately after the measurement.
Primary	Time needed to perform EE 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%.	Immediately after the measurement
Secondary	Accuracy and precision of VO2, VCO2, RQ and EE measurements.	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.	Immediately after the measurement.
Secondary	Coefficient of variation of VO2, VCO2, RQ and EE.	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.	Immediately after the measurement.
Secondary	Clinical condition restriction.	Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRG®.	Immediately after the measurement.