The ICALIC International Multicentric Study

NCT02796430 | Completed DMC

• 1 other identifier: 15-137
• Study Type: observational
• Target: 272
• Locations: 6 countries
• Sites: 7

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.

Conditions

Critical Illness

Keywords

Indirect calorimetry; critical care; mechanical ventilation; energy expenditure; ICALIC study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters

  immediately after the measurement

• Coefficient of variation (CV) of EE for different mechanical ventilators

  immediately after the measurement

• CV of EE when using different ventilation modes

  immediately after the measurement

• CV of EE in various ranges of oxygen and airway pressure support

  immediately after the measurement

• CV of EE when measured in different sedation/consciousness levels

  immediately after the measurement

Study Arms (1)

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; Other: Indirect calorimetry measurement

Interventions

Time needed to start indirect calorimetry measurement OTHER

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.

Mechanically ventilated patients

Indirect calorimetry measurement OTHER

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

Mechanically ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated adult ICU patients

You may qualify if:

• Mechanically ventilated adult ICU patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• European Society of Intensive Care Medicine: collaborator
• European Society for Clinical Nutrition and Metabolism: collaborator

Study Sites (7)

Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine

Vienna, Austria

Location

Department of Intensive Care, Vrije Universiteit Brussel

Brussels, Belgium

Location

Critical Care Medicine, Institute for Nutrition Research, Rabin Medical Center, Beilison Hospital

Petah Tikva, 49100, Israel

Location

Chiba University Hospital

Chiba, Japan

Location

Department of Anesthesiology and Intensive Care Medicine, Karolinska University Hospital

Huddinge, Sweden

Location

Service of Intensive Care, Geneva University Hospital

Geneva, 1211, Switzerland

Location

Adult Intensive care, Lausanne University Hospital

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claude Pichard, MD, PhD

  Clinical Nutrition, Geneva University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claude Pichard, MD, PhD

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 10, 2016
• Study Start: September 10, 2017
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); SE (1); BE (1); AU (1); IL (1); JP (1)