NCT02987309

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 18, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

November 18, 2016

Last Update Submit

February 25, 2020

Conditions

Nutrition AssessmentCritical IllnessChildren

Keywords

indirect calorimetrymethod comparison

Outcome Measures

Primary Outcomes (1)

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

    Comparison of measurements made by two different instruments

    2 hours

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children undergoing intensive care treatment

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0871, Norway

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gunnar Bentsen, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2016

First Posted

December 8, 2016

Study Start

March 30, 2017

Primary Completion

February 24, 2020

Study Completion

February 24, 2020

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)