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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01662011

Enrollment

Registered

2012-08-10

Start date

2010-01-31

Completion date

2012-12-31

Last updated

2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Mechanical Ventilation Complication

Keywords

patient-ventilator interaction, neurally adjusted ventilatory assist, diaphragm electrical activity, pressure support ventilation

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.

Interventions

DEVICEmode of neurally adjusted ventilatory assist

patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery

DEVICEMode of pressure support ventilation

Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Days to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Asynchrony index and Comfort Scale	2 weeks

Secondary

Measure	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

Countries

China

Contacts

Primary ContactLimin Zhu, MD

zhulimin121@hotmail.com8621-38626161

Backup ContactZhuoming Xu, MD PhD

zmxyfb@yahoo.com.cn8621-38626161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026