The ICALIC International Multicentric 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: Completed

Administrative data

• NCT number: NCT02796430
• Other study ID #: 15-137
• Status: Completed
• Start date: September 10, 2017
• Est. completion date: July 19, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the ease of use of the new calorimeter (Q-NRG (COSMED, Italy)) in intensive care unit (ICU) patients compared to currently used calorimeters (i.e. Quark RMR 1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as the stability and the feasibility of the measurements in various clinically relevant situations.

Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as the measure of the ease of use of the calorimeter.

Description:

Background and Aims:

This study aims at evaluating the ease of use of the new calorimeter for the measurement of energy expenditure (EE) in intensive care unit (ICU) patients. EE in ICU patients is highly variable depending on the severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support for the better clinical outcome. However, indirect calorimeters available on the market have insufficient accuracy for clinical and research use. Difficulties of handling and interpretation of results often limit IC in ICU patients. An accurate, easy-to-use calorimeter has been developed to meet these needs.

The Study Device:

The new calorimeter (Q-NRG, COSMED) is capable of IC measurements in mechanically ventilated patients without warm-up and limited calibration. The disposable in-line pneumotach flow meter and direct sampling of respiratory gas from the ventilator circuit enables the accurate measurement of oxygen consumption volume (VO2) and CO2 production volume (VCO2) to derive the energy expenditure. The software interface to manage the device and the collected data provides easy-to-use, user-friendly interface. Q-NRG does not bear the European Commission Conformity Mark (CE Mark), but has been approved by the Swiss authority for medical devices (Swissmedic) for use in this study. Q-NRG will be used in the way it is intended to be used as described in the instruction manual.

Currently used indirect calorimeters at each study center will be used as the comparator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• 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:
• Time needed to start indirect calorimetry measurement
Comparison of the time needed to start EE measurements by the new calorimeter and the currently used calorimeter, including the time needed for calibration, patient data input, connection to the ventilator circuit.
• Indirect calorimetry measurement
Comparison of EE measurements by the new calorimeter and the currently used calorimeter when using different mechanical ventilators, different ventilation modes, different patient conditions and severity

Locations

Country	Name	City	State
Austria	Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine	Vienna
Belgium	Department of Intensive Care, Vrije Universiteit Brussel	Brussels
Israel	Critical Care Medicine, Institute for Nutrition Research, Rabin Medical Center, Beilison Hospital	Petah Tikva
Japan	Chiba University Hospital	Chiba
Sweden	Department of Anesthesiology and Intensive Care Medicine, Karolinska University Hospital	Huddinge
Switzerland	Service of Intensive Care, Geneva University Hospital	Geneva
Switzerland	Adult Intensive care, Lausanne University Hospital	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	European Society for Clinical Nutrition and Metabolism (ESPEN), European Society of Intensive Care Medicine

Countries where clinical trial is conducted

Austria,  Belgium,  Israel,  Japan,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters	Time from the start-up of the devices until the 1st recorded measurement will be measured and compared between Q-NRG and the currently used indirect calorimeters, including time needed for patient information input, warm-up and calibrations according to the instructions for the devices, and installation of the device components needed for the measurements on patients.	immediately after the measurement
Secondary	Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters	EE measured by Q-NRG and currently used calorimeters will be compared to identify the differences of the characteristics of the measurements according to the different types of calorimeters.	immediately after the measurement
Secondary	Coefficient of variation (CV) of EE for different mechanical ventilators	CV of EE measured by Q-NRG when using different mechanical ventilators will be analyzed to evaluate the effects of the mechanical ventilators used during the indirect calorimetry measurement.	immediately after the measurement
Secondary	CV of EE when using different ventilation modes	CV of EE measured by Q-NRG when using different mechanical ventilation modes will be analyzed to evaluate the effect of different mechanical ventilation modes used during the indirect calorimetry measurement.	immediately after the measurement
Secondary	CV of EE in various ranges of oxygen and airway pressure support	CV of EE measured by the Q-NRG in different ranges of FiO2 will be analyzed to evaluate the difference in the stability of the measurements according to various FiO2 ranges.	immediately after the measurement
Secondary	CV of EE when measured in different sedation/consciousness levels	CV of EE measured by the Q-NRG in different levels of sedation/consciouness will be analyzed to evaluate the difference in the stability of the measurements according to various sedation/consciousness levels.	immediately after the measurement
Secondary	CV of EE when measured in different levels of patient severity	CV of EE measured by the Q-NRG in different levels of patient severity will be analyzed to evaluate the difference in the stability of the measurement according to various levels of severity.	immediately after the measurement