The ICALIC 2 International Multicentric Study

NCT03947294 | Terminated DMC

• 1 other identifier: 2019-00106
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Surgery; Hemodialysis

Keywords

Indirect calorimetry; Energy expenditure; VO2; VCO2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Accuracy and precision of VO2, VCO2, RQ and EE measurements.

  Immediately after the measurement.

• Coefficient of variation of VO2, VCO2, RQ and EE.

  Immediately after the measurement.

• Clinical condition restriction.

  Immediately after the measurement.

Other Outcomes (1)

• Accuracy of O2 and CO2 analysis.

  Immediately after the measurement.

Interventions

Q-NRG® DEVICE

Energy expenditure measurements

Also known as: Currently used calorimeters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis.

You may qualify if:

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

You may not qualify if:

• \< 18 years
• Intolerance or phobia to canopy or face mask
• Physical agitation or activity (\< 1hr before EE measurement)
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Sponsors & Collaborators

• Prof. Claude Pichard: lead

Study Sites (1)

Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35671611 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Clinical Nutrition

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: May 7, 2019
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)