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Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

NCT03824249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-03-04

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Indirect Calorimetry

Performance of indirect calorimetry in Canopy mode.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Thomas Langer, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

  • Edoardo Calderini, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

  • Carlo Agostoni, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-10
Primary Completion
2020-02-15
Completion
2021-12-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03824249 on ClinicalTrials.gov