Mechanical Ventilation ComplicationPhase 3NCT01662011
Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery
A Phase 3 study testing mode of neurally adjusted ventilatory assist and Mode of pressure support ventilation in people with Mechanical Ventilation Complication and Congenital Heart Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 days to 18 years
- Conditions the study is for
- Mechanical Ventilation Complication, Congenital Heart Disease
- What is being tested?
- mode of neurally adjusted ventilatory assist and Mode of pressure support ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients underwent cardiac surgery with biventricle repaired
- patients need mechanical ventilation more than 24hrs after cardiac surgery
Who cannot join
- age >18 years
- inappositely of catheter insertion
- hemodynamic instability
- coagulation disorders or bleeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, 200127
Limin Zhu, MD, 8621-38626161 ext. 6622, zhulimin121@hotmail.com
Zhuoming Xu, MD PhD, 8621-38626161 ext. 6623, zmxyfb@yahoo.com.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- mode of neurally adjusted ventilatory assist, Mode of pressure support ventilation
- Keywords
- patient-ventilator interaction, neurally adjusted ventilatory assist, diaphragm electrical activity, pressure support ventilation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mode of neurally adjusted ventilatory assistDevice
patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
Mode of pressure support ventilationDevice
Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery
| Study group | Role | What they receive |
|---|---|---|
| NAVA group | Experimental | Patients ventilated with the mode of neurally adjusted ventilatory assist Receives: Device: mode of neurally adjusted ventilatory assist |
| PSV group | Active comparator | Patients ventilated with the mode of pressure support ventilation. Receives: Device: Mode of pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony index and Comfort Scale
Measured: 2 weeks
Secondary outcomes (5)
Dosage of sedatives
Measured: 2 weeks
hemodynamics
Measured: 2 weeks
Duration of mechanical ventilation
Measured: 2 weeks
Gas exchange
Measured: 2 weeks
Length of ICU stay
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limin Zhu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Limin Zhu, MD, Study director, Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662011
- Sponsor's protocol ID
- SCMC-2010001
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2011
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery: the Effect of Patient-ventilator Interaction, Gas Exchange and Hemodynamics
- ClinicalTrials.gov ID
- NCT01662011
- Acronym / sponsor ID
- SCMC-2010001
- Keywords
- patient-ventilator interaction, neurally adjusted ventilatory assist, diaphragm electrical activity, pressure support ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA group | Experimental | Device: mode of neurally adjusted ventilatory assistPatients ventilated with the mode of neurally adjusted ventilatory assist |
| PSV group | Active comparator | Device: Mode of pressure support ventilationPatients ventilated with the mode of pressure support ventilation. |
Who may qualify
- Ages
- 7 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients underwent cardiac surgery with biventricle repaired
- patients need mechanical ventilation more than 24hrs after cardiac surgery
Key exclusion criteria (4 listed)
- age >18 years
- inappositely of catheter insertion
- hemodynamic instability
- coagulation disorders or bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mode of neurally adjusted ventilatory assistpatients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery | Device | NAVA group |
| Mode of pressure support ventilationPatients ventilated with the mode of pressure support ventilation after corrective open-heart surgery | Device | PSV group |
Primary outcome
Asynchrony index and Comfort Scale
Time frame: 2 weeks
5 secondary outcomes
Dosage of sedatives
Time frame: 2 weeks
hemodynamics
Time frame: 2 weeks
Duration of mechanical ventilation
Time frame: 2 weeks
Gas exchange
Time frame: 2 weeks
Length of ICU stay
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limin Zhu, MD study director
Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mode of neurally adjusted ventilatory assist and Mode of pressure support ventilation in people with Mechanical Ventilation Complication and Congenital Heart Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Limin Zhu, MD (8621-38626161 ext. 6622, zhulimin121@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony index and Comfort Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.