Actively Recruiting

Phase Not Applicable
Age: 0Minutes - 17Years
All Genders
NCT05511987

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

Led by University of Oklahoma · Updated on 2026-04-01

140

Participants Needed

1

Research Sites

224 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Minutes - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 17 years old or younger
  • Requires chest tube placement for spontaneous pneumothorax or lung surgery by a surgeon or surgical trainee at The Children's Hospital
Not Eligible

You will not qualify if you...

  • Age 18 years or older
  • Chest tube placed by a neonatologist or pediatrician
  • Malignant pleural effusion
  • Re-operation or emergency operation
  • Pre-operative chemotherapy, radiation, or history of these treatments within past 12 months
  • Renal or liver failure
  • Neurological dysfunction
  • Empyema

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

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Research Team

C

Catherine Hunter, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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