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

This study is currently recruiting participants.
Verified August 2012 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Limin Zhu, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01662011
First received: August 22, 2011
Last updated: August 7, 2012
Last verified: August 2012

August 22, 2011
August 7, 2012
January 2010
December 2011   (final data collection date for primary outcome measure)
Asynchrony index and Comfort Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01662011 on ClinicalTrials.gov Archive Site
  • Dosage of sedatives [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • hemodynamics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Gas exchange [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

  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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Mechanical Ventilation Complication
  • Congenital Heart Disease
  • Device: mode of neurally adjusted ventilatory assist
    patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
  • Device: Mode of pressure support ventilation
    Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery
  • Experimental: NAVA group
    Patients ventilated with the mode of neurally adjusted ventilatory assist
    Intervention: Device: mode of neurally adjusted ventilatory assist
  • Active Comparator: PSV group
    Patients ventilated with the mode of pressure support ventilation.
    Intervention: Device: Mode of pressure support ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact: Limin Zhu, MD 8621-38626161 ext 6622 zhulimin121@hotmail.com
Contact: Zhuoming Xu, MD PhD 8621-38626161 ext 6623 zmxyfb@yahoo.com.cn
China
 
NCT01662011
SCMC-2010001
Yes
Limin Zhu, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Study Director: Limin Zhu, MD Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
Shanghai Jiao Tong University School of Medicine
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP