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

Primary Purpose

Respiratory Insufficiency in Children, Noninvasive Ventilation, Nutrition Assessment

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Indirect Calorimetry
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Insufficiency in Children focused on measuring Energy Expenditure, Ventilator Weaning, Calorimetry, indirect

Eligibility Criteria

1 Month - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Spontaneous breathing

NIV-CPAP

NIV-PS

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Resting energy expenditure (REE)
Resting energy expenditure expressed in kcal/kg/die

Secondary Outcome Measures

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

Full Information

First Posted
January 29, 2019
Last Updated
March 3, 2022
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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1. Study Identification

Unique Protocol Identification Number
NCT03824249
Brief Title
Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency in Children, Noninvasive Ventilation, Nutrition Assessment
Keywords
Energy Expenditure, Ventilator Weaning, Calorimetry, indirect

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spontaneous breathing
Arm Type
Experimental
Arm Description
Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.
Arm Title
NIV-CPAP
Arm Type
Experimental
Arm 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.
Arm Title
NIV-PS
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Indirect Calorimetry
Other Intervention Name(s)
IC
Intervention Description
Performance of indirect calorimetry in Canopy mode.
Primary Outcome Measure Information:
Title
Resting energy expenditure (REE)
Description
Resting energy expenditure expressed in kcal/kg/die
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Carbon dioxide production (VCO2)
Description
Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min]
Time Frame
1 day
Title
Oxygen consumption (VO2)
Description
Quantity of oxygen consumed by the patients [expressed in ml/kg/min]
Time Frame
1 day
Title
Respiratory quotient (RQ)
Description
Respiratory quotient [expressed as VCO2/VO2]
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Langer, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edoardo Calderini, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlo Agostoni, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

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