MedDataX Logo

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

NCT ID: NCT01662011

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation Complication Congenital Heart Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

patient-ventilator interaction neurally adjusted ventilatory assist diaphragm electrical activity pressure support ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NAVA group

Patients ventilated with the mode of neurally adjusted ventilatory assist

Group Type EXPERIMENTAL

mode of neurally adjusted ventilatory assist

Intervention Type DEVICE

patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery

PSV group

Patients ventilated with the mode of pressure support ventilation.

Group Type ACTIVE_COMPARATOR

Mode of pressure support ventilation

Intervention Type DEVICE

Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mode of neurally adjusted ventilatory assist

patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery

Intervention Type DEVICE

Mode of pressure support ventilation

Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Limin Zhu

Attendant doctor, Department of thoracic and cardiovascular surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Limin Zhu, MD

Role: STUDY_DIRECTOR

Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Limin Zhu, MD

Role: CONTACT

Phone: 8621-38626161

Email: [email protected]

Zhuoming Xu, MD PhD

Role: CONTACT

Phone: 8621-38626161

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Limin Zhu, MD

Role: primary

Zhuoming Xu, MD PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCMC-2010001

Identifier Type: -

Identifier Source: org_study_id