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TerminatedNCT02987309Updated Feb 27, 2020

Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study

An observational study in Nutrition Assessment, Critical Illness and Children, sponsored by Oslo University Hospital. Terminated at 1 site in Norway. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-02-27.

Sponsored by Oslo University Hospital · Observational

Why this study was terminated
Equipment failure
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6
Ages
Up to 18 Years
Sex
All
01

Study summary

Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical status. There is however poor correlation between these calculations and actual energy consumption measured with indirect calorimetry (IC). Available equipment for IC has however been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated in modern ventilators. This functionality is easy to use, but we do not know if the results are reliable for children. This study is a method comparison study comparing measurements done with SensorMedics Vmax ("gold standard") vs GE Carescape (modern ventilator with Integrated IC) in children undergoing intensive care treatment.

02

Conditions studied

  • Nutrition Assessment
  • Critical Illness
  • Children

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Keywords

  • indirect calorimetry
  • method comparison
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 461 are open to participants now.

This study's enrollment of 6 is below the median of 132 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children undergoing intensive care treatment

Inclusion criteria

  • \< 18 years of age,
  • endotracheally intubated.
  • FiO2 \< 0,6, tube leak \< 10%, tidal volume > 50 ml.

Exclusion criteria

Exclusion Criteria:

  • Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient)

    Comparison of measurements made by two different instruments

    Time frame: 2 hours

07

Study locations

1 site
  • Oslo University Hospital, Rikshospitalet
    Oslo, 0871, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02987309
Lead sponsor
Oslo University Hospital
Responsible party
Gunnar Bentsen (Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Dec 8, 2016
Start date
Mar 30, 2017
Primary completion
Feb 24, 2020
Completion
Feb 24, 2020
Last update
Feb 27, 2020

Study contacts

Gunnar Bentsen, MD PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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