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Clinical Trials/NCT01662011
NCT01662011
Unknown
Phase 3

Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics

Shanghai Jiao Tong University School of Medicine1 site in 1 country72 target enrollmentJanuary 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Mechanical Ventilation Complication
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
72
Locations
1
Primary Endpoint
Asynchrony index and Comfort Scale
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Limin Zhu

Attendant doctor, Department of thoracic and cardiovascular surgery

Shanghai Jiao Tong University School of Medicine

Eligibility 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

Outcomes

Primary Outcomes

Asynchrony index and Comfort Scale

Time Frame: 2 weeks

Secondary Outcomes

  • 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 Sites (1)

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