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NCT02987309 Clinical Trial

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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02987309
Other study ID # 2016_InKal1
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 30, 2017
Est. completion date February 24, 2020

Study information
Verified date February 2020
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date February 24, 2020
Est. primary completion date February 24, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- < 18 years of age,

- endotracheally intubated.

- FiO2 < 0,6, tube leak < 10%, tidal volume > 50 ml.

Exclusion Criteria:

- Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital, Rikshospitalet Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary MEE (measured energy expenditure) kcal/kg/day, RQ (respiratory quotient) Comparison of measurements made by two different instruments 2 hours
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