Clinical trial Recruiting at 1 site Interventional Ages 0 Minutes to 17

Comparing digital and analog chest tube drainage systems in children

Official title: A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients

Run by University of Oklahoma · NCT05511987 · Data updated 2026-11-12

This study is testing whether a new digital chest tube drainage system works better than the traditional one for kids who need chest tubes for lung issues.

Quick facts

Study typeInterventional
Ages0 Minutes to 17 Years
SexAll
Enrollment140 (estimated)
SponsorUniversity of Oklahoma
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Oklahoma City, Oklahoma)
StatusRecruiting
StartedAugust 15, 2023
Main results expectedApril 2027
Study endsDecember 1, 2027
Registry record updatedApril 1, 2026
Trial IDNCT05511987 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pediatric patients aged 17 years or younger who require chest tube placement for specific conditions.

Probably not a fit

Patients over 17 years old or those with certain medical conditions such as malignant pleural effusion or neurological dysfunction may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Thopaz digital chest tube drainage system compared to the traditional analog system in pediatric patients requiring chest tube placement for spontaneous pneumothorax or pulmonary resection. It is a single-site, prospective randomized controlled trial conducted at The Children's Hospital at OU Health. Participants will be randomized to receive either the digital or analog system, and various outcomes such as duration of chest tube drainage, length of hospital stay, and complications will be measured. The study aims to fill a gap in the literature regarding the benefits of digital drainage systems in a pediatric population.

Why it matters

Potential benefit: If successful, this study could lead to improved management of chest tube drainage in children, potentially reducing hospital stays and complications.

How similar studies have gone: While there have been studies on digital drainage systems in adults, this is one of the first prospective trials specifically examining their use in pediatric patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Oklahoma
    Oklahoma City, Oklahoma, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.