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

Primary Purpose

Mechanical Ventilation Complication, Congenital Heart Disease

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
mode of neurally adjusted ventilatory assist
Mode of pressure support ventilation
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation Complication focused on measuring patient-ventilator interaction, neurally adjusted ventilatory assist, diaphragm electrical activity, pressure support ventilation

Eligibility Criteria

7 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NAVA group

PSV group

Arm Description

Patients ventilated with the mode of neurally adjusted ventilatory assist

Patients ventilated with the mode of pressure support ventilation.

Outcomes

Primary Outcome Measures

Asynchrony index and Comfort Scale

Secondary Outcome Measures

Dosage of sedatives
hemodynamics
Duration of mechanical ventilation
Gas exchange
Length of ICU stay

Full Information

First Posted
August 22, 2011
Last Updated
August 7, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01662011
Brief Title
Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery
Official Title
Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Congenital Heart Disease
Keywords
patient-ventilator interaction, neurally adjusted ventilatory assist, diaphragm electrical activity, pressure support ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAVA group
Arm Type
Experimental
Arm Description
Patients ventilated with the mode of neurally adjusted ventilatory assist
Arm Title
PSV group
Arm Type
Active Comparator
Arm Description
Patients ventilated with the mode of pressure support ventilation.
Intervention Type
Device
Intervention Name(s)
mode of neurally adjusted ventilatory assist
Intervention Description
patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
Intervention Type
Device
Intervention Name(s)
Mode of pressure support ventilation
Intervention Description
Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery
Primary Outcome Measure Information:
Title
Asynchrony index and Comfort Scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Dosage of sedatives
Time Frame
2 weeks
Title
hemodynamics
Time Frame
2 weeks
Title
Duration of mechanical ventilation
Time Frame
2 weeks
Title
Gas exchange
Time Frame
2 weeks
Title
Length of ICU stay
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limin Zhu, MD
Phone
8621-38626161
Ext
6622
Email
zhulimin121@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoming Xu, MD PhD
Phone
8621-38626161
Ext
6623
Email
zmxyfb@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Zhu, MD
Organizational Affiliation
Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Zhu, MD
Phone
8621-38626161
Ext
6622
Email
zhulimin121@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhuoming Xu, MD PhD
Phone
8621-38626161
Ext
6623
Email
zmxyfb@yahoo.com.cn

12. IPD Sharing Statement

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

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