Critical IllnessICALICNCT02796430
The ICALIC International Multicentric Study
An observational study of Critical Illness, run by University Hospital, Geneva at 7 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Time needed to start indirect calorimetry measurement and Indirect calorimetry measurement
- How many people
- 272 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 10 Sep 2017to 19 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated adult ICU patients
Who may be able to join
- Mechanically ventilated adult ICU patients
Who cannot join
- 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)
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- 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 locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Switzerland2 sites
Service of Intensive Care, Geneva University Hospital
Geneva, 1211
Adult Intensive care, Lausanne University Hospital
Lausanne, 1011
Austria1 site
Division of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine
Vienna
Belgium1 site
Department of Intensive Care, Vrije Universiteit Brussel
Brussels
Israel1 site
Critical Care Medicine, Institute for Nutrition Research, Rabin Medical Center, Beilison Hospital
Petah Tikva, 49100
Sweden1 site
Department of Anesthesiology and Intensive Care Medicine, Karolinska University Hospital
Huddinge
About this 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
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Time needed to start indirect calorimetry measurement, Indirect calorimetry measurement
- Keywords
- Indirect calorimetry, critical care, mechanical ventilation, energy expenditure, ICALIC study
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time needed to start indirect calorimetry measurementOther
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.
Indirect calorimetry measurementOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Time needed to start indirect calorimetry measurement; Other: Indirect calorimetry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the measurement
Secondary outcomes (6)
Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters
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.
Measured: immediately after the measurement
Coefficient of variation (CV) of EE for different mechanical ventilators
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.
Measured: immediately after the measurement
CV of EE when using different ventilation modes
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.
Measured: immediately after the measurement
CV of EE in various ranges of oxygen and airway pressure support
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.
Measured: immediately after the measurement
CV of EE when measured in different sedation/consciousness levels
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.
Measured: immediately after the measurement
CV of EE when measured in different levels of patient severity
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.
Measured: immediately after the measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start10 Sep 2017
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, European Society for Clinical Nutrition and Metabolism
- Responsible party
- Principal investigator, Prof. Claude Pichard, University Hospital, Geneva
- Investigators
- Claude Pichard, MD, PhD, Principal investigator, Clinical Nutrition, Geneva University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796430
- Sponsor's protocol ID
- 15-137
- Acronym
- ICALIC
- Status last verified
- Jul 2019
- First submitted
- 31 May 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02796430
- Acronym / sponsor ID
- ICALIC / 15-137
- Conditions
- Critical Illness
- Keywords
- Indirect calorimetry, critical care, mechanical ventilation, energy expenditure, ICALIC study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine, European Society for Clinical Nutrition and Metabolism
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | – | Other: Time needed to start indirect calorimetry measurement, Other: Indirect calorimetry measurementEase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated adult ICU patients
Key inclusion criteria (1 listed)
- Mechanically ventilated adult ICU patients
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time needed to start indirect calorimetry measurementComparison 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 | Mechanically ventilated patients |
| Indirect calorimetry measurementComparison 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 | Other | Mechanically ventilated patients |
Primary outcome
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.
6 secondary outcomes
Comparison of energy expenditure(EE) from Q-NRG and currently used calorimeters
Time frame: immediately after the measurement
Coefficient of variation (CV) of EE for different mechanical ventilators
Time frame: immediately after the measurement
CV of EE when using different ventilation modes
Time frame: immediately after the measurement
CV of EE in various ranges of oxygen and airway pressure support
Time frame: immediately after the measurement
CV of EE when measured in different sedation/consciousness levels
Time frame: immediately after the measurement
CV of EE when measured in different levels of patient severity
Time frame: immediately after the measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Pichard, MD, PhD principal investigator
Clinical Nutrition, Geneva University Hospital
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University Hospital, Geneva at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland, Austria, Belgium, Israel, Japan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time needed to start indirect calorimetry (IC) measurement in Q-NRG compared to currently used calorimeters (time frame: immediately after the measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.