Actively Recruiting
Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
Led by University of Oklahoma · Updated on 2026-04-01
140
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 17 years old or younger
- Requires chest tube placement for spontaneous pneumothorax or lung surgery by a surgeon or surgical trainee at The Children's Hospital
You will not qualify if you...
- Age 18 years or older
- Chest tube placed by a neonatologist or pediatrician
- Malignant pleural effusion
- Re-operation or emergency operation
- Pre-operative chemotherapy, radiation, or history of these treatments within past 12 months
- Renal or liver failure
- Neurological dysfunction
- Empyema
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
C
Catherine Hunter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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