An interventional study of sufentanil anesthesia and Hybrid closure in Pediatric Ventricular Septal Defects, sponsored by Nanjing Medical University. Completed. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2017-06-27.
Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment
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).
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 51 interventional studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
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.
Drug: sufentanil anesthesia · Procedure: Hybrid closure
Control group: Conventional closure of ventricular septal defects was aided with cardiopulmonary bypass.
Drug: sufentanil anesthesia · Procedure: Control
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.
Also known as: Sufentanil, Sufenta, (R-30730)
Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.
Also known as: TTMI: Transthoracic Minimally Invasive
Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
Also known as: CPB: cardiopulmonary bypass
Myocardial injury as measured by cardiac troponin I serum
Time frame: 7 days postoperatively after cardiac surgery
Respiratory dysfunction as measured by PaO2
Time frame: 7 days postoperatively after cardiac surgery
All cause mortality
Time frame: 7 days postoperatively after cardiac surgery
Number of participants with right bundle branch block assessed by ECG
Time frame: 7 days postoperatively after cardiac surgery
Left ventricular ejection fractions
Time frame: 7 days postoperatively after cardiac surgery
Extravascular lung water index
Time frame: 7 days postoperatively after cardiac surgery
No study locations are listed for this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Nanjing Medical University