Comparing digital and analog chest tube drainage systems in children
Official title: A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
Run by University of Oklahoma · NCT05511987 · Data updated 2026-11-12
This study is testing whether a new digital chest tube drainage system works better than the traditional one for kids who need chest tubes for lung issues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Minutes to 17 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | August 15, 2023 |
| Main results expected | April 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT05511987 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients aged 17 years or younger who require chest tube placement for specific conditions.
✕Probably not a fit
Patients over 17 years old or those with certain medical conditions such as malignant pleural effusion or neurological dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the Thopaz digital chest tube drainage system compared to the traditional analog system in pediatric patients requiring chest tube placement for spontaneous pneumothorax or pulmonary resection. It is a single-site, prospective randomized controlled trial conducted at The Children's Hospital at OU Health. Participants will be randomized to receive either the digital or analog system, and various outcomes such as duration of chest tube drainage, length of hospital stay, and complications will be measured. The study aims to fill a gap in the literature regarding the benefits of digital drainage systems in a pediatric population.
Why it matters
Potential benefit: If successful, this study could lead to improved management of chest tube drainage in children, potentially reducing hospital stays and complications.
How similar studies have gone: While there have been studies on digital drainage systems in adults, this is one of the first prospective trials specifically examining their use in pediatric patients.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Oklahoma
Oklahoma City, Oklahoma, United States Recruiting
Study contacts
- Principal investigator: Catherine Hunter, MD — University of Oklahoma
- Study coordinator: Catherine Hunter, MD
- Email: catherine-hunter@ouhsc.edu
- Phone: 2718001
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.