Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-10

Study Completion Date

2021-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Insufficiency in Children Noninvasive Ventilation Nutrition Assessment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spontaneous breathing

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

Group Type EXPERIMENTAL

Indirect Calorimetry

Intervention Type DIAGNOSTIC_TEST

Performance of indirect calorimetry in Canopy mode.

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.

Group Type EXPERIMENTAL

Indirect Calorimetry

Intervention Type DIAGNOSTIC_TEST

Performance of indirect calorimetry in Canopy mode.

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.

Group Type EXPERIMENTAL

Indirect Calorimetry

Intervention Type DIAGNOSTIC_TEST

Performance of indirect calorimetry in Canopy mode.

Interventions

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Indirect Calorimetry

Performance of indirect calorimetry in Canopy mode.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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IC

Eligibility Criteria

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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