Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Noninvasive Ventilation Clinical Trial

— CALO-NIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824249
• Other study ID #: 2019/834
• Status: Completed
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: February 2019
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2021
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Noninvasive Ventilation
• Nutrition Assessment
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Insufficiency in Children

Intervention

Diagnostic Test:
• Indirect Calorimetry
Performance of indirect calorimetry in Canopy mode.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting energy expenditure (REE)	Resting energy expenditure expressed in kcal/kg/die	1 day
Secondary	Carbon dioxide production (VCO2)	Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min]	1 day
Secondary	Oxygen consumption (VO2)	Quantity of oxygen consumed by the patients [expressed in ml/kg/min]	1 day
Secondary	Respiratory quotient (RQ)	Respiratory quotient [expressed as VCO2/VO2]	1 day