The ICALIC International Multicentric Study

University Hospitals (UH)

Status: Completed

Conditions: Critical Illness

Treatments: Other: Time needed to start indirect calorimetry measurement; Other: Indirect calorimetry measurement

Study type: Observational

Funder types: Other

Identifiers

NCT02796430

15-137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

272 participants in 1 patient group

Mechanically ventilated patients

Description:

Ease of use will be assessed by analysing the time needed to start indirect calorimetry measurement, and results of indirect calorimetry measurements by both the new indirect calorimeter and the currently used calorimeters at each study center.

Treatment:

Other: Indirect calorimetry measurement

Other: Time needed to start indirect calorimetry measurement