Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care. Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.

Detailed Description
-----------------
Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates. In this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.

Official Title
-----------------
Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care

Conditions
-----------------
Respiration

Intervention / Treatment
-----------------
* Device: Triggering mode of the ventilator
* Device: Triggering method of the ventilator
* Device: Triggering method of the ventilator
* Device: Triggering method of the ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children born over 30 weeks of gestation needing ventilatory care Exclusion Criteria: Craniofacial malformation which does not allow feeding tobe positioning. Critical ventilatory or perfusion problems.

Ages Eligible for Study
-----------------
Maximum Age: 17 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Flow triggering | Device: Triggering mode of the ventilator<br>* 10 min of each triggering mode<br>Device: Triggering method of the ventilator<br>* Flow triggering<br>|
| Active Comparator: 2<br>Pressure triggering | Device: Triggering mode of the ventilator<br>* 10 min of each triggering mode<br>Device: Triggering method of the ventilator<br>* Pressure triggering<br>|
| Active Comparator: 3<br>NAVA triggering | Device: Triggering mode of the ventilator<br>* 10 min of each triggering mode<br>Device: Triggering method of the ventilator<br>* NAVA triggering<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time in ventilator-patient synchrony in each of the assist modes. |  | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilatory care, children, intensive care, asynchrony, triggering, Children needing ventilatory care