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

August 7, 2012 updated by: Limin Zhu, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asynchrony index and Comfort Scale
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Dosage of sedatives
Time Frame: 2 weeks
2 weeks
hemodynamics
Time Frame: 2 weeks
2 weeks
Duration of mechanical ventilation
Time Frame: 2 weeks
2 weeks
Gas exchange
Time Frame: 2 weeks
2 weeks
Length of ICU stay
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMC-2010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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