Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

NCT03824249 | Completed

• 1 other identifier: 2019/834
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency in Children; Noninvasive Ventilation; Nutrition Assessment

Keywords

Energy Expenditure; Ventilator Weaning; Calorimetry, indirect

Outcome Measures

Primary Outcomes (1)

• Resting energy expenditure (REE)

  Resting energy expenditure expressed in kcal/kg/die

  1 day

Secondary Outcomes (3)

• Carbon dioxide production (VCO2)

  1 day

• Oxygen consumption (VO2)

  1 day

• Respiratory quotient (RQ)

  1 day

Study Arms (3)

Spontaneous breathing

EXPERIMENTAL

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

Diagnostic Test: Indirect Calorimetry

NIV-CPAP

EXPERIMENTAL

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

NIV-PS

EXPERIMENTAL

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

Interventions

Indirect Calorimetry DIAGNOSTIC_TEST

Performance of indirect calorimetry in Canopy mode.

Also known as: IC

NIV-CPAP; NIV-PS; Spontaneous breathing

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• age \> 6 years
• patients whose parents didn't provide signed informed consent

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Study Officials

• Thomas Langer, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

  PRINCIPAL INVESTIGATOR

• Edoardo Calderini, 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: February 10, 2019
• Primary Completion: February 15, 2020
• Study Completion: December 15, 2021
• Last Updated: March 4, 2022

Record last verified: 2019-02

Locations

IT (1)