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The ICALIC Accuracy Validation in Geneva Study

Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter for Energy Expenditure Measurement in ICU Patients: The ICALIC International Multicentric Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02790697
Acronym
ICALIC
Enrollment
30
Registered
2016-06-06
Start date
2017-09-10
Completion date
2019-12-31
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Indirect calorimetry, ICALIC Study, Energy expenditure, VO2, VCO2, Respiratory quotient

Brief summary

This study aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be conducted in Geneva center. The measurements made with the new calorimeter will be compared to the measurements by the mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition analysis.

Detailed description

Indirect calorimetry is a method to measure energy expenditure of human subjects by analyzing patient breath gas to measure the amount (volume) of oxygen consumption (VO2) and CO2 production (VCO2). Energy expenditure is calculated by the Weir's equation using the measured VO2 and VCO2 values. The new calorimeter is equipped with a disposable in-line pneumotach flowmeter, which measures the flow of exhaled gas of patients directly within the mechanical ventilator circuit. It also samples small amount of inhaled and exhaled gas to measure the inhaled and exhaled O2 and CO2 compositions. The new dynamic micro-mixing chamber technique is used to meaure VO2 and VCO2 to derive the energy expenditure. The mass spectrometer measures the inhaled and exhaled gas compositions. The mass spectrometer samples inhaled gas from the mechanical ventilator circuit. A mixing chamber system is used to collect the expired gas from the outlet of the mechanical ventilator. The collected gas is measured for the second time after diluting with a constant flow of ambient air, which is monitored by an independent mass flow meter. The volume of the expired gas is calculated by comparison of the concentrations of exhaled gas before and after the dilution. The measurements will be used to calculate the VO2 and VCO2 to derive the energy expenditure.

Interventions

OTHERIndirect calorimetry

Indirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Mechanically ventilated adult ICU patients

Exclusion criteria

* Fraction of inhaled oxygen (FIO2) \> 70% * Positive end expiratory pressure (PEEP) \>10cmH2O * Peak ventilatory pressure \> 30cmH2O * Presence of air leaks from thoracic drain tube * Changes in vasoactive agent dose (\>20%, \<1 hr before and/or during IC) * Agitation or change in sedative dose (\>20%, \<1 hr before and/or during IC) * Change in body temperature (\>0.5°C, \<1 hr before and/or during IC) * Expected duration of ICU stay \< 24 hours * Expected survival of the patient \< 24 hours

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Energy expenditureimmediately after the measurementEnergy expenditure calculated as a result of VO2 and VCO2 measurements

Secondary

MeasureTime frameDescription
Accuracy of VO2immediately after the measurementVolume of oxygen consumption
Accuracy of VCO2immediately after the measurementVolume of CO2 production
Respiratory quotient (RQ)immediately after the measurementRQ calculated as a ratio of VCO2 to VO2

Countries

Switzerland

Contacts

Primary ContactTaku Oshima, MD,PhD
Oshima.Taku@hcuge.ch+41 79 5534780
Backup ContactSeverine Graf
Severine.Graf@hcuge.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026