Nutrition AssessmentNCT02987309
Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study
An observational study of Nutrition Assessment and Critical Illness, run by Oslo University Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Nutrition Assessment, Critical Illness, Children
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- 30 Mar 2017to 24 Feb 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing intensive care treatment
Who may be able to join
- < 18 years of age,
- endotracheally intubated.
- FiO2 < 0,6, tube leak < 10%, tidal volume > 50 ml.
Who cannot join
- Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nutrition Assessment, Critical Illness, Children
- Keywords
- indirect calorimetry, method comparison
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient)
Comparison of measurements made by two different instruments
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start30 Mar 2017
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: Equipment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition AssessmentStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Bentsen, Oslo University Hospital
- Investigators
- Gunnar Bentsen, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987309
- Sponsor's protocol ID
- 2016_InKal1
- Status last verified
- Feb 2020
- First submitted
- 18 Nov 2016
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study
- ClinicalTrials.gov ID
- NCT02987309
- Acronym / sponsor ID
- 2016_InKal1
- Conditions
- Nutrition Assessment, Critical Illness, Children
- Keywords
- indirect calorimetry, method comparison
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Equipment failure
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 8 Dec 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing intensive care treatment
Key inclusion criteria (3 listed)
- < 18 years of age,
- endotracheally intubated.
- FiO2 < 0,6, tube leak < 10%, tidal volume > 50 ml.
Key exclusion criteria (1 listed)
- Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient)
Time frame: 2 hours
Comparison of measurements made by two different instruments
Results and safety
The study was stopped early (reason given: Equipment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- 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.
Gunnar Bentsen, MD PhD principal investigator
Oslo 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 Nutrition Assessment and Critical Illness, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Feb 2020. 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 Norway. 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 was stopped early (reason given: Equipment failure). Results are not available in the source record.
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?
MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient) (time frame: 2 hours). 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 Feb 2020.