Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis

NCT ID: NCT04018079

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2018-10-30

Brief Summary

Background:

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.

Methods:

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.

Detailed Description

Methods:

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.

Conditions

Congenital Heart Disease in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• All cases had clinical as well as echocardiographic proof of hemodynamically critical PDA.

Exclusion Criteria

• Patients with silent PDA.
• irreversible pulmonary vascular disease.
• those who had associated hemodynamically significant congenital heart disease (CHD).

• Minimum Eligible Age: 8 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdel Bary Ahmed Ibrahim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Abdel-Bary M, Abdel-Baseer KA, Abdel-Latif AF, Abdel-Naser MA, Nafie M, Eisa KM. Left ventricular dysfunction postsurgical patent ductus arteriosus ligation in children: predictor factors analysis. J Cardiothorac Surg. 2019 Sep 18;14(1):168. doi: 10.1186/s13019-019-0990-z.

Reference Type: DERIVED

PMID: 31533759 (View on PubMed)

Other Identifiers

South Valley University 1513

Identifier Type: -

Identifier Source: org_study_id