The ICALIC International Multicentric Study

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Critical Illness

Clinical Trial Details

NCT number	NCT02796430
Study type	Observational
Source	University Hospital, Geneva
Contact
Status	Completed
Phase
Start date	September 10, 2017
Completion date	July 19, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The ICALIC International Multicentric Study — ICALIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms