A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
University of Oklahoma
Summary
In 2007 the Thopaz digital drainage system was launched as one of the first chest tube drainage systems to utilize a digital rather than analog device. The digital system allows for stored data, objective measurement of air leaks as well as maintaining a constant pleural pressure. The adult literature describes multiple benefits of using a digital drainage system, only two studies to date have looked at pediatric patients. In the adult literature, reported benefits include shorter chest tube drainage times, decreased length of stay, cost savings and fewer chest x-rays. To date, there have been no prospective randomized controlled trials comparing digital versus analog chest tube drainage systems in pediatric patients. In addition, the only two pediatric studies which looked at the potential benefits of a digital drainage system only looked at its use in patients who underwent pulmonary resection. Thus, a gap in the literature exists for a prospective trial determining if there is benefit to using a digital vs analog drainage system in pediatric patients requiring a chest tube. The investigators hypothesize that pediatric patients who are placed on the Thopaz+ digital drainage system will have decreased duration of chest tube drainage, fewer chest x-rays and shorter duration of air leaks compared to patients using a traditional analog chest tube drainage system. This will be the first prospective randomized study exploring the potential benefits of using a digital chest tube drainage system in pediatric patients.
Description
This study will be a single site prospective randomized controlled study of all pediatric patients (age ≤17 years old) requiring a chest tube placed for spontaneous pneumothorax or pulmonary resection by a pediatric surgery fellow, faculty or general surgery faculty at The Children's Hospital at OU Health. Pediatric patients who meet inclusion criteria will be identified by pediatric surgery residents, fellows or staff. Upon receiving consent prior to chest tube placement, patients will be randomized to using either the digital (Thopaz+) or analog (Pleur-evac) drainage system. This is an inves…
Eligibility
- Age range
- 0–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * age≤17 years old * requiring chest tube placement for spontaneous pneumothorax or pulmonary resection by a surgeon (or surgical trainee) at The Children's Hospital Exclusion Criteria: * age≥18-year-old * chest tube placement by neonatologist or pediatrician, * malignant pleural effusion * re-operation or emergent operation * pre-operative chemotherapy or radiation or history of chemotherapy or radiation within the past 12 months * renal or hepatic failure * neurological dysfunction * empyema
Interventions
- DeviceMadela THOPAZ Digital Device
Digital drainage systems use electronic sensors to measure changes in pressure and thus may allow for quantification of the degree of air leak continuously and provide a graphical representation of the trend over time. Data on intrapleural pressure are also provided by some units. Together, these data may lead to expedited chest tube removal and hospital discharge with obvious financial implications.
- DeviceAtrium Analog Device
Analog drainage systems contain a sequentially numbered series of columns in the water seal chamber. The degree of air leak is assessed by observing the highest numbered column in which bubbling occurs. This provides a qualitative assessment at a specific point in time. This assessment, however, is subject to interobserver variability and does not account for variation over time.
Location
- University of OklahomaOklahoma City, Oklahoma