The ICALIC Accuracy Validation in Geneva Study

• Conditions: Critical Illness
• Interventions: Other: Indirect calorimetry

• Registration Number: NCT02790697
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-06
• Study Start: 2017-09-10
• Primary Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-27
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated ICU patient	Indirect calorimetry	Indirect calorimetry measurements will be conducted using the new calorimeter and the mass spectrometer system at the same time for all enrolled patients.

Primary Outcome Measures

Name	Time	Method
Accuracy of Energy expenditure	immediately after the measurement	Energy expenditure calculated as a result of VO2 and VCO2 measurements

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service of Intensive Care, Geneva University Hospital; 🇨🇭 Geneva, Switzerland