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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Mechanical Ventilation Complication
Congenital Heart Disease
Device: mode of neurally adjusted ventilatory assist
Device: Mode of pressure support ventilation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Asynchrony index and Comfort Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAVA group
Patients ventilated with the mode of neurally adjusted ventilatory assist
Device: mode of neurally adjusted ventilatory assist
patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
Active Comparator: PSV group
Patients ventilated with the mode of pressure support ventilation.
Device: Mode of pressure support ventilation
Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662011

Contacts
Contact: Limin Zhu, MD 8621-38626161 ext 6622 zhulimin121@hotmail.com
Contact: Zhuoming Xu, MD PhD 8621-38626161 ext 6623 zmxyfb@yahoo.com.cn

Locations
China
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University Recruiting
Shanghai, China, 200127
Contact: Limin Zhu, MD    8621-38626161 ext 6622    zhulimin121@hotmail.com   
Contact: Zhuoming Xu, MD PhD    8621-38626161 ext 6623    zmxyfb@yahoo.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Limin Zhu, MD Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
  More Information

No publications provided

Responsible Party: Limin Zhu, Attendant doctor, Department of thoracic and cardiovascular surgery, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01662011     History of Changes
Other Study ID Numbers: SCMC-2010001
Study First Received: August 22, 2011
Last Updated: August 7, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
patient-ventilator interaction
neurally adjusted ventilatory assist
diaphragm electrical activity
pressure support ventilation

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 28, 2014