Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Respiratory Insufficiency in Children, Noninvasive Ventilation, Nutrition Assessment

Intervention / Treatment
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* Diagnostic Test: Indirect Calorimetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spontaneous breathing<br>Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry. | Diagnostic Test: Indirect Calorimetry<br>* Performance of indirect calorimetry in Canopy mode.<br>* Other names: IC;|
| Experimental: NIV-CPAP<br>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. | Diagnostic Test: Indirect Calorimetry<br>* Performance of indirect calorimetry in Canopy mode.<br>* Other names: IC;|
| Experimental: NIV-PS<br>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. | Diagnostic Test: Indirect Calorimetry<br>* Performance of indirect calorimetry in Canopy mode.<br>* Other names: IC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting energy expenditure (REE) | Resting energy expenditure expressed in kcal/kg/die | 1 day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy Expenditure, Ventilator Weaning, Calorimetry, indirect