Noninvasive Ventilation Clinical Trial
— CALO-NIVOfficial 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
Verified date | February 2019 |
Source | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
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 |
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 |
NCT03687385 -
The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients
|
N/A | |
Not yet recruiting |
NCT03687424 -
Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults?
|
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 | |
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 | |
Not yet recruiting |
NCT04904484 -
A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients
|
N/A |