Clinical trial NCT02796430: The ICALIC International Multicentric Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Indirect calorimetry
critical care
mechanical ventilation
energy expenditure
ICALIC study
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
name: European Society for Clinical Nutrition and Metabolism
First posted: 2016-06-10
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated adult ICU patients

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters
timeFrame: immediately after the measurement
Secondary outcomes:
measure: Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters
timeFrame: immediately after the measurement
measure: Coefficient of variation (CV) of EE for different mechanical ventilators
timeFrame: immediately after the measurement
measure: CV of EE when using different ventilation modes
timeFrame: immediately after the measurement
measure: CV of EE in various ranges of oxygen and airway pressure support
timeFrame: immediately after the measurement
measure: CV of EE when measured in different sedation/consciousness levels
timeFrame: immediately after the measurement
measure: CV of EE when measured in different levels of patient severity
timeFrame: immediately after the measurement
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine
city: Brussels
country: Belgium
facility: Department of Intensive Care, Vrije Universiteit Brussel
city: Petah Tikva
country: Israel
facility: Critical Care Medicine, Institute for Nutrition Research, Rabin Medical Center, Beilison Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Huddinge
country: Sweden
facility: Department of Anesthesiology and Intensive Care Medicine, Karolinska University Hospital
city: Geneva
country: Switzerland
facility: Service of Intensive Care, Geneva University Hospital
city: Lausanne
country: Switzerland
facility: Adult Intensive care, Lausanne University Hospital
Study officials:
affiliation: Clinical Nutrition, Geneva University Hospital
name: Claude Pichard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: