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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 3

Conditions: Mechanical Ventilation Complication; Congenital Heart Disease

Treatments: Device: Mode of pressure support ventilation; Device: mode of neurally adjusted ventilatory assist

Study type: Interventional

Funder types: Other

Identifiers

NCT01662011

SCMC-2010001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 7 days to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

NAVA group

Experimental group

Description:

Patients ventilated with the mode of neurally adjusted ventilatory assist

Treatment:

Device: mode of neurally adjusted ventilatory assist

PSV group

Active Comparator group

Description:

Patients ventilated with the mode of pressure support ventilation.

Treatment:

Device: Mode of pressure support ventilation