Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

NCT03824249 — Not applicable, Completed, 20 participants, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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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

Registry	NCT03824249, acronym CALO-NIV
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, diagnostic
Enrollment	20 (Actual)
Sponsor	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)
Conditions	Respiratory Insufficiency in Children, Noninvasive Ventilation, Nutrition Assessment
Interventions	Indirect Calorimetry (Diagnostic test)
Dates	start 2019-02-10, primary completion 2020-02-15, completion 2021-12-15, first posted 2019-01-31, last updated 2022-03-04
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Spontaneous breathing	Experimental	Diagnostic Test: Indirect Calorimetry	Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.
NIV-CPAP	Experimental	Diagnostic Test: 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.
NIV-PS	Experimental	Diagnostic Test: 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.

Indirect Calorimetry (Diagnostic test), also known as IC: Performance of indirect calorimetry in Canopy mode.

+Outcome measures

Primary outcomes

Resting energy expenditure (REE) [1 day]: Resting energy expenditure expressed in kcal/kg/die

Secondary outcomes

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 \[expressed as VCO2/VO2\]

+Eligibility

Sex: All, ages: 1 Month to 6 Years

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

+Locations (1)

Facility	City	Country	Status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Italy

+Investigators

Thomas Langer, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Edoardo Calderini, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Carlo Agostoni, MD, Study chair, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano