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:
Shanghai Jiao Tong University School of Medicine
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
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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:
- To evaluate the effect of the patient-ventilator interaction in children underwent open-heart surgery when ventilated with NAVA, compared with conventional mechanical ventilation.
- 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
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 May 16, 2013