Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery

Study Overview
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Brief Summary
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Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort. It was a controlled randomized single-center prospective study in order to explore the efficacy of this new mode of mechanical ventilation after corrective open-heart surgery for congenital heart disease.

Detailed Description
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To evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with NAVA, compared with conventional mechanical ventilation. To verify the benefits of NAVA in improving the gas exchange and hemodynamics after biventricle repair for CHD.

Official Title
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Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics

Conditions
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Mechanical Ventilation Complication, Congenital Heart Disease

Intervention / Treatment
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* Device: mode of neurally adjusted ventilatory assist
* Device: Mode of pressure support ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients underwent cardiac surgery with biventricle repaired patients need mechanical ventilation more than 24hrs after cardiac surgery Exclusion Criteria: age >18 years inappositely of catheter insertion hemodynamic instability coagulation disorders or bleeding inclusion in other research protocol

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVA group<br>Patients ventilated with the mode of neurally adjusted ventilatory assist | Device: mode of neurally adjusted ventilatory assist<br>* patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery<br>|
| Active Comparator: PSV group<br>Patients ventilated with the mode of pressure support ventilation. | Device: Mode of pressure support ventilation<br>* Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony index and Comfort Scale |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of sedatives |  | 2 weeks | 
| hemodynamics |  | 2 weeks | 
| Duration of mechanical ventilation |  | 2 weeks | 
| Gas exchange |  | 2 weeks | 
| Length of ICU stay |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient-ventilator interaction, neurally adjusted ventilatory assist, diaphragm electrical activity, pressure support ventilation