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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01662011
• Other study ID #: SCMC-2010001
• Status: Recruiting
• Phase: Phase 3
• First received: August 22, 2011
• Last updated: August 7, 2012
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Limin Zhu, MD
• Phone: 8621-38626161
• Email: zhulimin121[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Mechanical Ventilation Complication

Intervention

Device:
• mode of neurally adjusted ventilatory assist
patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
• Mode of pressure support ventilation
Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery

Locations

Country	Name	City	State
China	Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony index and Comfort Scale		2 weeks	No
Secondary	Dosage of sedatives		2 weeks	No
Secondary	hemodynamics		2 weeks	No
Secondary	Duration of mechanical ventilation		2 weeks	No
Secondary	Gas exchange		2 weeks	No
Secondary	Length of ICU stay		2 weeks	No