Pediatric Ventricular Septal Defects
Conditions
Brief summary
Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric VSD in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. On the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric VSD, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (CPB).
Interventions
DRUGsufentanil anesthesia
Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.
PROCEDUREHybrid closure
Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.
PROCEDUREControl
Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* confirmed diagnosis of perimembranous ventricular septal defect, muscular ventricular septal defect, doubly committed subarterial VSD by transesophageal echocardiogram (TEE) with VSD size 5-12mm; * no significant aortic insufficiency or aortic valve prolapse.
Exclusion criteria
* confirmed pulmonary hypertension (systolic pulmonary arterial pressure \>75mmHg or pulmonary vascular resistance \>8.0 Wood U/m2); * more than mild degree of aortic regurgitation and obvious aortic valve prolapse; * preoperative congestive heart failure; * other coexisting cardiac anomalies; * infective endocarditis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial injury as measured by cardiac troponin I serum | 7 days postoperatively after cardiac surgery |
| Respiratory dysfunction as measured by PaO2 | 7 days postoperatively after cardiac surgery |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality | 7 days postoperatively after cardiac surgery |
Other
| Measure | Time frame |
|---|---|
| Number of participants with right bundle branch block assessed by ECG | 7 days postoperatively after cardiac surgery |
| Left ventricular ejection fractions | 7 days postoperatively after cardiac surgery |
| Extravascular lung water index | 7 days postoperatively after cardiac surgery |
Outcome results
None listed