Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation (CALO-NIV)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Respiratory Insufficiency in Children; Noninvasive Ventilation; Nutrition Assessment

Treatments: Diagnostic Test: Indirect Calorimetry

Study type: Interventional

Funder types: Other

Identifiers

NCT03824249

2019/834

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 1 month to 6 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Spontaneous breathing

Experimental group

Description:

Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.

Treatment:

Diagnostic Test: Indirect Calorimetry

NIV-CPAP

Experimental group

Description:

Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 centimeters of water (cmH2O). CPAP will be applied via single-limb circuit with intentional leak.

Treatment:

Diagnostic Test: Indirect Calorimetry

NIV-PS

Experimental group

Description:

Performance of indirect calorimetry in children undergoing Non-invasive continuous positive airway pressure (CPAP) of 4 cmH2O and Pressure support (PS) of 8 cmH2O. Non-invasive ventilation will be applied via single-limb circuit with intentional leak.

Treatment:

Diagnostic Test: Indirect Calorimetry