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The ICALIC International Multicentric Study (ICALIC)

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ClinicalTrials.gov Identifier: NCT02796430
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
European Society of Intensive Care Medicine
The European Society for Clinical Nutrition and Metabolism
Information provided by (Responsible Party):
Prof. Claude Pichard, University Hospital, Geneva

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.


Condition or disease Intervention/treatment
Critical Illness Other: Time needed to start indirect calorimetry measurement Other: Indirect calorimetry measurement

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.


Study Type : Observational
Estimated Enrollment : 343 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 10, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : September 30, 2018

Group/Cohort Intervention/treatment
Mechanically ventilated patients
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.
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.

Other: 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




Primary Outcome Measures :
  1. Time needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters [ Time Frame: immediately after the measurement ]
    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.


Secondary Outcome Measures :
  1. Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters [ Time Frame: immediately after the measurement ]
    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.

  2. Coefficient of variation (CV) of EE for different mechanical ventilators [ Time Frame: immediately after the measurement ]
    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.

  3. CV of EE when using different ventilation modes [ Time Frame: immediately after the measurement ]
    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.

  4. CV of EE in various ranges of oxygen and airway pressure support [ Time Frame: immediately after the measurement ]
    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.

  5. CV of EE when measured in different sedation/consciousness levels [ Time Frame: immediately after the measurement ]
    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.

  6. CV of EE when measured in different levels of patient severity [ Time Frame: immediately after the measurement ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated adult ICU patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796430


Contacts
Contact: Taku Oshima, MD, PhD +41795534780 oshima.taku@hcuge.ch
Contact: Claude Pichard, MD, PhD +41223729345 Claude.Pichard@hcuge.ch

Locations
Austria
Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine Not yet recruiting
Vienna, Austria
Contact: Michael Hiesmayr, MD       michael.hiesmayr@meduniwien.ac.at   
Belgium
Department of Intensive Care, Vrije Universiteit Brussel Not yet recruiting
Brussels, Belgium
Contact: Elisabeth DeWaele, MD, PhD       Elisabeth.DeWaele@uzbrussel.be   
Israel
Critical Care Medicine, Institute for Nutrition Research, Rabin Medical Center, Beilison Hospital Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Pierre Singer, MD       psinger@clalit.org.il   
Norway
Department of Anaesthesiology and Intensive Care Haukeland University Hospital Not yet recruiting
Bergen, Norway, 5021
Contact: Anne Berit Guttormsen, MD, PhD       anne.guttormsen@helse-bergen.no   
Sweden
Department of Anesthesiology and Intensive Care Medicine, Karolinska University Hospital Not yet recruiting
Huddinge, Sweden
Contact: Jan Wernerman, MD,PhD       jan.wernerman@karolinska.se   
Switzerland
Service of Intensive Care, Geneva University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Claudia-Paula Heidegger, MD       claudia-paula.heidegger@hcuge.ch   
Contact: Severine Graf       Severine.Graf@hcuge.ch   
Adult Intensive care, Lausanne University Hospital Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Mette M Berger, MD, PhD       Mette.Berger@chuv.ch   
Sponsors and Collaborators
University Hospital, Geneva
European Society of Intensive Care Medicine
The European Society for Clinical Nutrition and Metabolism
Investigators
Principal Investigator: Claude Pichard, MD, PhD Clinical Nutrition, Geneva University Hospital

Responsible Party: Prof. Claude Pichard, Claude Pichard, MD, PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02796430     History of Changes
Other Study ID Numbers: 15-137
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Claude Pichard, University Hospital, Geneva:
Indirect calorimetry
critical care
mechanical ventilation
energy expenditure
ICALIC study

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes