The ICALIC Accuracy Validation in Geneva Study

Critical Illness Clinical Trial

— ICALIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02790697
• Other study ID #: 15-137_Addendum
• Status: Recruiting
• Start date: September 10, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Geneva
• Contact: Taku Oshima, MD ,PhD
• Phone: +41 79 5534780
• Email: Oshima.Taku[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Switzerland	Service of Intensive Care, Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Energy expenditure	Energy expenditure calculated as a result of VO2 and VCO2 measurements	immediately after the measurement
Secondary	Accuracy of VO2	Volume of oxygen consumption	immediately after the measurement
Secondary	Accuracy of VCO2	Volume of CO2 production	immediately after the measurement
Secondary	Respiratory quotient (RQ)	RQ calculated as a ratio of VCO2 to VO2	immediately after the measurement