We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01662011
Recruitment Status : Unknown
Verified August 2012 by Limin Zhu, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : August 10, 2012
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2010
Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Asynchrony index and Comfort Scale [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Dosage of sedatives [ Time Frame: 2 weeks ]
  2. hemodynamics [ Time Frame: 2 weeks ]
  3. Duration of mechanical ventilation [ Time Frame: 2 weeks ]
  4. Gas exchange [ Time Frame: 2 weeks ]
  5. Length of ICU stay [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Limin Zhu, 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
Cardiovascular Diseases