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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NCT05511987

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

Recruiting
NAAges 0–17InterventionalDiagnostic
University of Oklahoma
~140 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Madela THOPAZ Digital DeviceAtrium Analog Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.
Measured over 2 years
Air Leakage
1 sites across 1 states
Oklahoma1
  • Catherine Hunter, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

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Eligibility criteria

Inclusion

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

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
  • 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.