NCT05511987 Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
| NCT ID | NCT05511987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Air Leakage |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-08-15 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Catherine Hunter, MD
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT05511987 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 17 Years, studying Air Leakage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05511987 currently recruiting?
Yes, NCT05511987 is actively recruiting participants. Contact the research team at catherine-hunter@ouhsc.edu for enrollment information.
Where is the NCT05511987 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT05511987 clinical trial?
NCT05511987 is sponsored by University of Oklahoma. The principal investigator is Catherine Hunter, MD at University of Oklahoma. The trial plans to enroll 140 participants.