Suspended

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

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What is being tested

mode of neurally adjusted ventilatory assist

+ Mode of pressure support ventilation

Device
Who is being recruted

Congenital Abnormalities+3

+ Cardiovascular Diseases

+ Heart Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorShanghai Jiao Tong University School of Medicine
Study ContactLimin Zhu, MDMore contacts
Last updated: August 10, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01662011
Principal SponsorShanghai Jiao Tong University School of Medicine
Study ContactLimin Zhu, MDMore contacts
Last updated: August 10, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular AbnormalitiesHeart Defects, Congenital

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients ventilated with the mode of neurally adjusted ventilatory assist

Group II

Active Comparator
Patients ventilated with the mode of pressure support ventilation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University

Shanghai, ChinaOpen Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University in Google Maps
SuspendedOne Study Center