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

Phase 3

• Conditions: Mechanical Ventilation Complication; Congenital Heart Disease
• Interventions: Device: mode of neurally adjusted ventilatory assist; Device: Mode of pressure support ventilation

• Registration Number: NCT01662011
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

1. To evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with NAVA, compared with conventional mechanical ventilation.

2. To verify the benefits of NAVA in improving the gas exchange and hemodynamics after biventricle repair for CHD.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-08-22
• Primary Completion: 2011-12
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAVA group	mode of neurally adjusted ventilatory assist	Patients ventilated with the mode of neurally adjusted ventilatory assist
PSV group	Mode of pressure support ventilation	Patients ventilated with the mode of pressure support ventilation.

Primary Outcome Measures

Name	Time	Method
Asynchrony index and Comfort Scale	2 weeks

Secondary Outcome Measures

Name	Time	Method
Dosage of sedatives	2 weeks
hemodynamics	2 weeks
Duration of mechanical ventilation	2 weeks
Gas exchange	2 weeks
Length of ICU stay	2 weeks

Trial Locations

Locations (1)

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University; 🇨🇳 Shanghai, China