Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
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|ClinicalTrials.gov Identifier: NCT04018079|
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care.
A retrospective study included fifty children with isolated PDA treated by surgical ligation from June 2015 to June 2018. Their mean age was 15.78 ± 7.58 months and 72% were females. The LV dimensions and systolic function were assessed by two-dimensional echocardiography pre PDA ligation. The mean duct size was 4.08 ± 1.25 mm.
|Condition or disease|
|Congenital Heart Disease in Children|
Study population Fifty children with PDA, for whom surgical PDA ligation was done from June 2015 to June 2018. All cases were operated in cardiothoracic surgery department and were followed up by cardiothoracic surgeons and paediatricians at cardiac surgery ICU, Qena University Hospital. Their mean age at intervention was 15.78 ± 7.58 months, body surface area (BSA) 0.43±0.03 and 32 (72%) were females. The mean duct diameter was 4.08 ± 1.25 mm. The study conforms to the ethical standards of the Helsinki Declaration and approval was obtained from the institutional ethics committee of Qena Faculty of Medicine.
Surgical technique PDA ligation was performed under general anaesthesia after pre-operative anaesthetic evaluation. After single endotracheal tube anaesthesia induction; children were placed on the right lateral recumbent position fixed with adhesive plaster and a pad under the chest, the left arm raised above the head. A left mini-thoracotomy incision is done parallel to the medial border of the scapula and entrance to the thoracic cavity was via the third or fourth intercostal space. Cautiously, the ductus is identified and dissected carefully. Then it was doubly ligated with silk ligature (2/0 or 0). An intercostal tube inserted during operation and removed within 48 hours if no drainage presents.
Descriptive statistical analysis Data were arranged and analyzed utilizing Version 20 of the SPSS program (Statistical Package for Social Sciences). Continuous variables were compared using the Student paired t-test and are expressed as mean values ± standard deviation. Pearson Chi-Square tests were used to detect differences among groups for categorical variables. The relationship between PDA size and changes in echocardiographic parameters was verified using the Pearson linear correlation and the linear regression analysis. P-value of <0.05 was considered of significance.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||50 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Left Ventricular Dysfunction Post Surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis|
|Actual Study Start Date :||June 1, 2015|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||October 30, 2018|
- Comparison between the echocardiographic changes before PDA ligation to the follow up changes at one day, one month and six months post PDA ligation. [ Time Frame: echocardiography was done before PDA ligation; and follow up at one day, one month and six months post ligation. ]the echocardiographic data included: The LV end-diastolic dimension (LVEDd) in mm, LV end-systolic dimension (LVESd) in mm, PDA size in mm, left atrial to aortic diameter ratio (LA/Ao ratio), EF % and FS %
- identification of the preoperative predictor factors of LV dysfunction following PDA surgical ligation in children [ Time Frame: all data were collected pre ligation; at one day, one month and six months post ligation ]we classified our patients into two gatherings as indicated by FS % based on a definition of LV systolic dysfunction; group I with FS ≤ 29% and group II with FS > 29%.