The ICALIC Accuracy Validation in Geneva Study (ICALIC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Other: Indirect calorimetry

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Service of Intensive Care, Geneva University Hospital
    • Contact: Severine Graf; Email: Severine.Graf@hcuge.ch
    • Contact: Claudia-Paula Heidegger, MD; Email: claudia-paula.heidegger@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated adult ICU patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanically ventilated ICU patient; Indirect calorimetry measurements will be conducted using the new calorimeter and the mass spectrometer system at the same time for all enrolled patients.	Other: Indirect calorimetry; Indirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Energy expenditure	Energy expenditure calculated as a result of VO2 and VCO2 measurements	immediately after the measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of VO2	Volume of oxygen consumption	immediately after the measurement
Accuracy of VCO2	Volume of CO2 production	immediately after the measurement
Respiratory quotient (RQ)	RQ calculated as a ratio of VCO2 to VO2	immediately after the measurement

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Claude Pichard, MD, PhD, Clinical Nutrition, Geneva University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: May 31, 2016
• First Posted (Estimate): June 6, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Energy expenditure; VO2; Indirect calorimetry; VCO2; ICALIC Study; Respiratory quotient
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 15-137_Addendum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No