Clinical Trials Logo
  1. Home
  2. Noninvasive Ventilation
  3. NCT03824249
  4. Details
NCT03824249 Clinical Trial

Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Noninvasive Ventilation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03824249
Other study ID # 2019/834
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2019
Est. completion date December 15, 2021

Study information
Verified date February 2019
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 15, 2021
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Month to 6 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Indirect Calorimetry
Performance of indirect calorimetry in Canopy mode.

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resting energy expenditure (REE) Resting energy expenditure expressed in kcal/kg/die 1 day
Secondary Carbon dioxide production (VCO2) Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min] 1 day
Secondary Oxygen consumption (VO2) Quantity of oxygen consumed by the patients [expressed in ml/kg/min] 1 day
Secondary Respiratory quotient (RQ) Respiratory quotient [expressed as VCO2/VO2] 1 day
See also
  Status Clinical Trial Phase
Completed NCT02845076 - Weaning From Noninvasive Ventilation N/A
Recruiting NCT05008211 - Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients N/A
Completed NCT03250416 - Management of Noninvasive Ventilation in Hypoxemic Patients
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Recruiting NCT01791335 - NIV and Glottis-diaphragm Synchrony N/A
Recruiting NCT04165382 - Development, Implementation and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV) N/A
Completed NCT04912544 - Facilitating Patient Communication During Noninvasive Ventilation N/A
Recruiting NCT03728452 - Trophic Nutrition in Patients Submitted to High Flow Oxygen Therapy and / or Non Invasive Mechanical Ventilation
Active, not recruiting NCT03499470 - Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV N/A
Not yet recruiting NCT05964244 - Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure N/A
Recruiting NCT03053973 - The Effects of Nocturnal Non-invasive Ventilation in Stable COPD N/A
Terminated NCT04413643 - NIV for COPD: Hospital to Home N/A
Completed NCT03151317 - Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV
Completed NCT03607357 - High Flow Nasal Oxygen and Acute Left Heart Failure N/A
Withdrawn NCT02615834 - Chest Pressure for Intubated Peds Patients N/A
Not yet recruiting NCT02383719 - Mask Comfort Feasibility N/A
Not yet recruiting NCT06260202 - Nutrition Under Noninvasive Ventilation
Completed NCT03876873 - Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults N/A
Completed NCT02267291 - Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters N/A