Effects of NIV and CPAP on Ventilation Distribution, Measured by EIT, During Deep Sedation in Paediatric Patients

Study Overview
=================
Brief Summary
-----------------
In patients undergoing spontaneous breathing (SB) deep sedation there is a re-distribution of ventilation towards lungs non-dependant areas (ventral areas in supine position). Non-invasive ventilation (NIV), offering positive pressure, should favour a better ventilation of dependant areas (dorsal areas in supine position), making ventilation more homogeneous and increasing functional residual capacity. Electrical impedance tomography (EIT) is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable; it allows to study ventilation distribution, and it can measure and calculate also parameters that are related to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as anaesthesia or PEEP-application. Uses of EIT in paediatric age are described in literature, but it has never been described as being used in Non-Operating Room Anaesthesia, nor in other cases of SB deep sedation. In addition, the impact of NIV on the distribution of ventilation in healthy paediatric patients undergoing deep sedation has never been described.

Official Title
-----------------
Effects of Non-invasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) on Ventilation Distribution, Measured by Electrical Impedance Tomography (EIT), During Deep Sedation in Paediatric Patients

Conditions
-----------------
Respiratory Failure, Sedation, Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Device: EIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paediatric age (from 1 to 10 years old) ASA score ≤ 2 Sedation time ≥ 30 min Exclusion Criteria: ASA score ≥ 3 Lung pathologies (such as asthma, bronchopulmonary dysplasia, obstructive sleep apnoea) Preterm infant Severe obesity Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis) Neuromuscular, mitochondrial, metabolic or chromosomal disease with hypotonia CPAP or NIV treatment at home Hand-Bag Ventilation (HBV) during the procedure (loss of the respiratory drive) Non-Total IntraVenous Anaesthesia (TIVA), adherence to the sedation protocol Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spontaneous breathing<br>Electrical impedance tomography (EIT). | Device: EIT<br>* Evaluation of ventilation distrinution during deep sedation through EIT<br>|
| Active Comparator: CPAP mode<br>Electrical impedance tomography (EIT). | Device: EIT<br>* Evaluation of ventilation distrinution during deep sedation through EIT<br>|
| Active Comparator: NIV- S/T mode<br>Electrical impedance tomography (EIT). | Device: EIT<br>* Evaluation of ventilation distrinution during deep sedation through EIT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional Ventilation Delay (pixels %), RDV | It's an index of atelectrauma, supra-distension and in general an inhomogeneous ventilation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhomogeneity Index (pixels), GI |  | 1 day | 
| Gravity Centre(pixels %), GC |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIV; CPAP; EIT;