Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Not Applicable

Completed

• Conditions: Respiratory Insufficiency in Children; Nutrition Assessment; Noninvasive Ventilation
• Interventions: Diagnostic Test: Indirect Calorimetry

• Registration Number: NCT03824249
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Status Verified: 2019-02
• Study Start: 2019-02-10
• Primary Completion: 2020-02-15
• Study Completion: 2021-12-15
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NIV-PS	Indirect Calorimetry	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.
NIV-CPAP	Indirect Calorimetry	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.
Spontaneous breathing	Indirect Calorimetry	Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.

Primary Outcome Measures

Name	Time	Method
Resting energy expenditure (REE)	1 day	Resting energy expenditure expressed in kcal/kg/die

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy