A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients

What this Trial Is About

Researchers are investigating the use of digital versus analog chest tube drainage systems in pediatric patients aged 17 years and younger who require chest tubes due to spontaneous pneumothorax or pulmonary resection. The study addresses a gap in pediatric research, as only two prior studies have explored digital drainage in children, and none have prospectively compared digital and analog systems. The adult literature suggests digital systems may reduce chest tube duration, length of hospital stay, chest x-rays, and costs, which this trial aims to evaluate in children. This prospective randomized controlled trial takes place at a single site and enrolls pediatric patients who will be randomly assigned to either the Thopaz+ digital drainage system or the traditional analog Pleur-evac system. Randomization is stratified by surgery type (pulmonary resection or spontaneous pneumothorax) using sealed envelopes. The study is unblinded, and the digital system uses sensors to measure air leaks and maintain constant pleural pressure, while the analog system uses a water chamber to detect air leaks based on visible bubbling. Participants will be followed during their hospital stay to record chest tube drainage duration, length of stay, time to first ambulation, number of chest x-rays, complications like pneumonia, and presence of air leaks defined by device-specific criteria. Data collection will continue until an adequate sample size is reached. Results will be analyzed to compare outcomes between the two groups, with the primary outcome focused on device performance over two years. Individual results will remain confidential, and de-identified data may be used for future research.

Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients