The ICALIC Accuracy Validation in Geneva Study
ICALIC
Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter for Energy Expenditure Measurement in ICU Patients: The ICALIC International Multicentric Study
1 other identifier
observational
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedStudy Start
First participant enrolled
September 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 27, 2019
September 1, 2019
1.3 years
May 31, 2016
September 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of Energy expenditure
Energy expenditure calculated as a result of VO2 and VCO2 measurements
immediately after the measurement
Secondary Outcomes (3)
Accuracy of VO2
immediately after the measurement
Accuracy of VCO2
immediately after the measurement
Respiratory quotient (RQ)
immediately after the measurement
Study Arms (1)
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.
Interventions
Indirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service of Intensive Care, Geneva University Hospital
Geneva, 1211, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claude Pichard, MD, PhD
Clinical Nutrition, Geneva University Hospital
Central Study Contacts
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 6, 2016
Study Start
September 10, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2019
Last Updated
September 27, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share