Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 10, 2012
August 1, 2012
1.9 years
August 22, 2011
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asynchrony index and Comfort Scale
2 weeks
Secondary Outcomes (5)
Dosage of sedatives
2 weeks
hemodynamics
2 weeks
Duration of mechanical ventilation
2 weeks
Gas exchange
2 weeks
Length of ICU stay
2 weeks
Study Arms (2)
NAVA group
EXPERIMENTALPatients ventilated with the mode of neurally adjusted ventilatory assist
PSV group
ACTIVE COMPARATORPatients ventilated with the mode of pressure support ventilation.
Interventions
patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery
Eligibility Criteria
You may qualify if:
- patients underwent cardiac surgery with biventricle repaired
- patients need mechanical ventilation more than 24hrs after cardiac surgery
You may not qualify if:
- age \>18 years
- inappositely of catheter insertion
- hemodynamic instability
- coagulation disorders or bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, 200127, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Limin Zhu, MD
Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attendant doctor, Department of thoracic and cardiovascular surgery
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 10, 2012
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
August 10, 2012
Record last verified: 2012-08