Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children. Open label randomized controlled trial.
Not Applicable
- Conditions
- Patent ductus arteriosus
- Registration Number
- PACTR201207000395469
- Lead Sponsor
- MEPI CVD linked project
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
All patients with a confirmed diagnosis of patent ductus arteriosus aged 12 years and below and whose guardians have consented
Exclusion Criteria
History of bronchospasm or found to have bronchospasms during pre-operative assessment.
Other combined chest surgery taking place at the time of PDA ligation.
Intraoperative damage to thoracic duct or Ductus Arteriosus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The combined primary endpoint constituted the following complications; significant pleural space accumulation (pleural separation >30mm) at 48 hours post operatively or need for increased postoperative oxygen supplementation (>1L/min) or drainage site infection (seen as purulent discharge at the tube drain site).
- Secondary Outcome Measures
Name Time Method ICU stay beyond 24 hours from the time of post-operative admission.