Comparing Digital vs. Analog Chest Tube Drainage in Children
This study is comparing two types of chest tube drainage systems for children who need a chest tube due to an air leak, such as from a collapsed lung (spontaneous pneumothorax) or after lung surgery. One system is the Madela THOPAZ Digital Device, which uses electronic sensors to measure air leaks and pressure. The other is the Atrium Analog Device, which uses water to show air leaks. The study wants to see if the digital system offers benefits like shorter chest tube drainage times or hospital stays, similar to what has been seen in adults. We are looking for children aged 17 years or younger who need a chest tube placed by a surgeon at The Children's Hospital. The study's status is currently unclear, and it plans to enroll 140 patients.
- Study design
- This is a prospective randomized controlled study. Participants will be assigned by chance to either the digital (Thopaz+) or analog (Pleur-evac) drainage system.
- What's involved
- You will be followed while in the hospital to track how long the chest tube is needed, your length of stay, and how long until you can walk.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, comparing the two devices, will be measured at 2 years.
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Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Catherine Hunter, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.2 years
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems will be compaired. The systems will be measured in cmH2O.