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Trial record 40 of 55 for:    cancer AND energy restriction

The ICALIC 2 International Multicentric Study (ICALIC2)

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ClinicalTrials.gov Identifier: NCT03947294
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Claude Pichard, University Hospital, Geneva

Brief Summary:
Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

Condition or disease Intervention/treatment
Cancer Surgery Hemodialysis Device: Q-NRG®

Detailed Description:

This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.


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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter in Canopy and Face Mask Modes for Energy Expenditure Measurement: The ICALIC 2 International Multicentric Study (Second Phase)
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : November 6, 2020
Estimated Study Completion Date : May 31, 2021

Intervention Details:
  • Device: Q-NRG®
    Energy expenditure measurements
    Other Name: Currently used calorimeters


Primary Outcome Measures :
  1. Time needed to perform EE measurement. [ Time Frame: Immediately after the measurement ]
    Time needed to perform EE will be calculated from the time the Q-NRG® or the currently used calorimeter is turned on to EE measurement reaches a steady state with a variation ≤10%.


Secondary Outcome Measures :
  1. Accuracy and precision of VO2, VCO2, RQ and EE measurements. [ Time Frame: Immediately after the measurement. ]
    Accuracy and precision of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.

  2. Coefficient of variation of VO2, VCO2, RQ and EE. [ Time Frame: Immediately after the measurement. ]
    The stability of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.

  3. Clinical condition restriction. [ Time Frame: Immediately after the measurement. ]
    Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRG®.


Other Outcome Measures:
  1. Accuracy of O2 and CO2 analysis. [ Time Frame: Immediately after the measurement. ]
    Accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® assessed by comparison with a mass spectrometer.



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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
Spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis.
Criteria

Inclusion Criteria:

All spontaneously breathing adult patients (≥ 18 years) referred to the Nutrition Unit in the context of malnutrition, cancer, surgery or haemodialysis.

Exclusion Criteria:

  1. < 18 years
  2. Intolerance or phobia to canopy or face mask
  3. Physical agitation or activity (< 1hr before EE measurement)
  4. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

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): NCT03947294


Contacts
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Contact: Claude Pichard +41223729345 claude.pichard@unige.ch
Contact: Yves M Dupertuis +41223723389 yves.m.dupertuis@hcuge.ch

Locations
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Switzerland
Geneva University Hospital Recruiting
Geneva, Geneva 14, Switzerland, 1211
Contact: Claude Pichard    +41223729345    claude.pichard@unige.ch   
Contact: Yves M Dupertuis    +41223723389    yves.m.dupertuis@hcuge.ch   
Sponsors and Collaborators
Prof. Claude Pichard

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Responsible Party: Prof. Claude Pichard, Head, Clinical Nutrition, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03947294     History of Changes
Other Study ID Numbers: 2019-00106
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Energy expenditure
VO2
VCO2