Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Study Overview
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Brief Summary
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The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not. The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.

Detailed Description
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Asynchrony means that the timing of support given by 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 our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.

Official Title
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Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Conditions
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Ventilation

Intervention / Treatment
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* Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
* Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes Exclusion Criteria: Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: NAVA<br>Children randomised in this arm will be treated with neurally adjusted ventilatory assist | Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)<br>* Treatment with neurally adjusted ventilatory assist<br>|
| Active Comparator: Control<br>Patients randomized to control group will be treated with pressure controlled ventilation (PC) when they are newborns and older children in this group will be treated with pressure regulated volume controlled (PRVC) ventilation. | Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)<br>* Treatment with PC or PRVC ventilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is the duration of mechanical ventilation |  | 30minutes-3weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of sedative medication needed |  | 30minutes-3weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventilatory care, children, intensive care, NAVA, Children needing ventilatory care