Comparing digital and analog chest tube drainage systems in children
A Randomized Controlled Trial of a Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
NA · University of Oklahoma · NCT05511987
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 0 Minutes to 17 Years |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05511987 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 17 years or younger who require chest tube placement for specific conditions.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Catherine Hunter, MD — University of Oklahoma
- Study coordinator: Catherine Hunter, MD
- Email: catherine-hunter@ouhsc.edu
- Phone: 2718001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Air Leakage, chest tube