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

Recruiting now · Not applicable

Conditions studied: Air Leakage

In brief

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.

Key facts

Study ID

NCT05511987

Run by

University of Oklahoma

People needed

140

Starts

2023-08-15

Expected to finish

2027-12-01

Last updated by the study team

2026-04-01

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.