Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03824249

Acronym

CALO-NIV

Enrollment

Registered

2019-01-31

Start date

2019-02-10

Completion date

2021-12-15

Last updated

2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninvasive Ventilation, Nutrition Assessment, Respiratory Insufficiency in Children

Keywords

Energy Expenditure, Ventilator Weaning, Calorimetry, indirect

Brief summary

Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. For this reason, actual measurement of resting energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better approach. Currently, IC is not validated during the use of non-invasive ventilation. Aim of the present study is to validate the measurement of REE with IC in pediatric patients undergoing non-invasive ventilation through a single-limb circuit with intentional leak.

Interventions

DIAGNOSTIC_TESTIndirect Calorimetry

Performance of indirect calorimetry in Canopy mode.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 6 Years

Healthy volunteers

Inclusion criteria

* children admitted to the Pediatric Intensive Care Unit who completed the weaning phase from non-invasive ventilation. * age ≤ 6 years * patients whose parents provided signed informed consent

Exclusion criteria

* age \> 6 years * patients whose parents didn't provide signed informed consent

Design outcomes

Primary

Measure	Time frame	Description
Resting energy expenditure (REE)	1 day	Resting energy expenditure expressed in kcal/kg/die

Secondary

Measure	Time frame	Description
Carbon dioxide production (VCO2)	1 day	Quantity of carbon dioxide exhaled by the patients \[expressed in ml/kg/min\]
Oxygen consumption (VO2)	1 day	Quantity of oxygen consumed by the patients \[expressed in ml/kg/min\]
Respiratory quotient (RQ)	1 day	Respiratory quotient \[expressed as VCO2/VO2\]

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026