Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off-pump hybrid closure | Active Comparator | Hybrid closure is that a periventricular technique uses an occluding device to closure ventricular septal defects of patients through the delivery system by transthoracic minimally invasive small incision without cardiopulmonary bypass. |
|
| Control | Placebo Comparator | Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sufentanil anesthesia | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 7 days postoperatively after cardiac surgery |
| Measure | Description | 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 | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hai-tao Gu, MD, PhD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14752435 | Background | Amin Z, Danford DA, Lof J, Duncan KF, Froemming S. Intraoperative device closure of perimembranous ventricular septal defects without cardiopulmonary bypass: preliminary results with the perventricular technique. J Thorac Cardiovasc Surg. 2004 Jan;127(1):234-41. doi: 10.1016/j.jtcvs.2003.08.023. | |
| 29941505 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Hybrid closure | Procedure | Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision. |
|
|
| Control | Procedure | Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy. |
|
|
| Extravascular lung water index |
| 7 days postoperatively after cardiac surgery |
| Liu H, Lu FX, Zhou J, Yan F, Qian SC, Li XY, Zheng SQ, Chen JQ, Zhong JS, Feng QL, Ding T, Fan J, Gu HT, Liu XC. Minimally invasive perventricular versus open surgical ventricular septal defect closure in infants and children: a randomised clinical trial. Heart. 2018 Dec;104(24):2035-2043. doi: 10.1136/heartjnl-2017-312793. Epub 2018 Jun 25. |
| D009204 |
| Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |