Critical IllnessICALICNCT02790697
The ICALIC Accuracy Validation in Geneva Study
An observational study of Critical Illness, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This study aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be conducted in Geneva center. 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?
- Indirect calorimetry
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2017to 31 Dec 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
1 site in 1 country.
Severine Graf contact
Switzerland1 site, 1 recruiting
- Recruiting
Service of Intensive Care, Geneva University Hospital
Geneva, 1211
Claudia-Paula Heidegger, MD, claudia-paula.heidegger@hcuge.ch
Severine Graf, Severine.Graf@hcuge.ch
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 aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be conducted in Geneva center.
The measurements made with the new calorimeter will be compared to the measurements by the mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition analysis.
Read the detailed description
Indirect calorimetry is a method to measure energy expenditure of human subjects by analyzing patient breath gas to measure the amount (volume) of oxygen consumption (VO2) and CO2 production (VCO2). Energy expenditure is calculated by the Weir's equation using the measured VO2 and VCO2 values.
The new calorimeter is equipped with a disposable in-line pneumotach flowmeter, which measures the flow of exhaled gas of patients directly within the mechanical ventilator circuit. It also samples small amount of inhaled and exhaled gas to measure the inhaled and exhaled O2 and CO2 compositions. The new dynamic micro-mixing chamber technique is used to meaure VO2 and VCO2 to derive the energy expenditure.
The mass spectrometer measures the inhaled and exhaled gas compositions. The mass spectrometer samples inhaled gas from the mechanical ventilator circuit. A mixing chamber system is used to collect the expired gas from the outlet of the mechanical ventilator. The collected gas is measured for the second time after diluting with a constant flow of ambient air, which is monitored by an independent mass flow meter. The volume of the expired gas is calculated by comparison of the concentrations of exhaled gas before and after the dilution. The measurements will be used to calculate the VO2 and VCO2 to derive the energy expenditure.
- Conditions
- Critical Illness
- Being tested
- Indirect calorimetry
- Keywords
- Indirect calorimetry, ICALIC Study, Energy expenditure, VO2, VCO2, Respiratory quotient
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect calorimetryOther
Indirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated ICU patient | Indirect calorimetry measurements will be conducted using the new calorimeter and the mass spectrometer system at the same time for all enrolled patients. Receives: Other: Indirect calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Energy expenditure
Energy expenditure calculated as a result of VO2 and VCO2 measurements
Measured: immediately after the measurement
Secondary outcomes (3)
Accuracy of VO2
Volume of oxygen consumption
Measured: immediately after the measurement
Accuracy of VCO2
Volume of CO2 production
Measured: immediately after the measurement
Respiratory quotient (RQ)
RQ calculated as a ratio of VCO2 to VO2
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 posted6 Jun 2016 (estimated)
- Study start10 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- 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
- NCT02790697
- Sponsor's protocol ID
- 15-137_Addendum
- Acronym
- ICALIC
- Status last verified
- Sep 2019
- First submitted
- 31 May 2016
- Last updated
- 27 Sep 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 27 Sep 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
- NCT02790697
- Acronym / sponsor ID
- ICALIC / 15-137_Addendum
- Conditions
- Critical Illness
- Keywords
- Indirect calorimetry, ICALIC Study, Energy expenditure, VO2, VCO2, Respiratory quotient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 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 aims at validating the accuracy of the new indirect calorimeter (Q-NRG, COSMED, Italy), developed for the ICALIC multicenter study. The validation of accuracy will only be conducted in Geneva center.
The measurements made with the new calorimeter will be compared to the measurements by the mixing chamber method using a mass spectrometer (MAX300-LG, Extrel, USA) for gas composition analysis.
Detailed description
Indirect calorimetry is a method to measure energy expenditure of human subjects by analyzing patient breath gas to measure the amount (volume) of oxygen consumption (VO2) and CO2 production (VCO2). Energy expenditure is calculated by the Weir's equation using the measured VO2 and VCO2 values.
The new calorimeter is equipped with a disposable in-line pneumotach flowmeter, which measures the flow of exhaled gas of patients directly within the mechanical ventilator circuit. It also samples small amount of inhaled and exhaled gas to measure the inhaled and exhaled O2 and CO2 compositions. The new dynamic micro-mixing chamber technique is used to meaure VO2 and VCO2 to derive the energy expenditure.
The mass spectrometer measures the inhaled and exhaled gas compositions. The mass spectrometer samples inhaled gas from the mechanical ventilator circuit. A mixing chamber system is used to collect the expired gas from the outlet of the mechanical ventilator. The collected gas is measured for the second time after diluting with a constant flow of ambient air, which is monitored by an independent mass flow meter. The volume of the expired gas is calculated by comparison of the concentrations of exhaled gas before and after the dilution. The measurements will be used to calculate the VO2 and VCO2 to derive the energy expenditure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated ICU patient | – | Other: Indirect calorimetryIndirect calorimetry measurements will be conducted using the new calorimeter and the mass spectrometer system at the same time for all enrolled patients. |
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 |
|---|---|---|
| Indirect calorimetryIndirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer. | Other | Mechanically ventilated ICU patient |
Primary outcome
Accuracy of Energy expenditure
Time frame: immediately after the measurement
Energy expenditure calculated as a result of VO2 and VCO2 measurements
3 secondary outcomes
Accuracy of VO2
Time frame: immediately after the measurement
Accuracy of VCO2
Time frame: immediately after the measurement
Respiratory quotient (RQ)
Time frame: immediately after the measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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.
Severine Graf contact
Claude Pichard, MD, PhD principal investigator
Clinical Nutrition, Geneva University Hospital
1 site in 1 country: 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 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taku Oshima, MD,PhD (+41 79 5534780, Oshima.Taku@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Energy expenditure (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 27 Sep 2019.