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

March 3, 2022 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spontaneous breathing
Performance of indirect calorimetry in spontaneously breathing children through the use of indirect calorimetry.
Diagnostic test: Indirect Calorimetry
Performance of indirect calorimetry in Canopy mode.
Other Names:
  • IC
Experimental: NIV-CPAP
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
Performance of indirect calorimetry in Canopy mode.
Other Names:
  • IC
Experimental: NIV-PS
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
Performance of indirect calorimetry in Canopy mode.
Other Names:
  • IC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Thomas Langer, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
  • Study Chair: Carlo Agostoni, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2019

Primary Completion (Actual)

February 15, 2020

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/834

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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