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

RecruitingNAAges 0 Minutes - 17 YearsAllUniversity of Oklahoma
NCT05511987 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
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
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What it tests

  • Madela THOPAZ Digital Device
  • Atrium Analog Device
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Where

1 site
University of Oklahoma
Oklahoma City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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