Digital vs. Analog Chest Drainage Systems for Pediatric Air Leak
(THOPAZ Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Digital Chest Tube Drainage System (Thopaz+) for pediatric air leak?
Is the digital chest drainage system safe for use in children?
Digital chest drainage systems have been used safely in adults and are being explored for use in children, with some studies suggesting they may improve treatment time and patient mobility compared to traditional systems. However, there is limited experience and data specifically in the pediatric population, so more research is needed to fully understand their safety in children.12456
How does the digital chest drainage system differ from traditional treatments for pediatric air leaks?
What is the purpose of this trial?
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.
Research Team
Catherine Hunter, MD
Principal Investigator
University of Oklahoma
Eligibility Criteria
This trial is for children and teens up to 17 years old who need a chest tube placed due to a collapsed lung or after lung surgery at The Children's Hospital. It excludes those with cancerous fluid in the lungs, recent chemo or radiation, major organ failure, brain function issues, pus in the lung cavity, adults over 18, or if the tube is placed by neonatologists or pediatricians.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either the digital (Thopaz+) or analog (Pleur-evac) drainage system and monitored for duration of chest tube drainage, length of stay, and air leaks.
Follow-up
Participants are monitored for safety and effectiveness after chest tube removal, including tracking of complications and recovery progress.
Data Analysis
Interim analysis will be performed once 12 patients per arm are accrued, with continued monitoring until the study is adequately powered.
Treatment Details
Interventions
- Analog Chest Tube Drainage System
- Digital Chest Tube Drainage System (Thopaz+)
Analog Chest Tube Drainage System is already approved in European Union, United States for the following indications:
- Pulmonary resection
- Pneumothorax
- Thoracic trauma
- Pleural disease
- Pulmonary resection
- Pneumothorax
- Thoracic trauma
- Pleural disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor