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NCT05511987 · ClinicalTrials.gov registry record · NA
Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients
A NA study of Air Leakage, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05511987: Recruiting NA study of Air Leakage, sponsored by University of Oklahoma.
NCT05511987 is a NA study of Air Leakage that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 140 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05511987, a NA study of Air Leakage, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Madela THOPAZ Digital Device
- DEVICE Atrium Analog Device
Study Locations (1)
Oklahoma
- University of Oklahoma - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2025-07-01 |
| Phase | NA |
What NCT05511987 shows while recruiting
NCT05511987 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Air Leakage appearing as the primary indexed condition, and to 2 interventions - of which Madela THOPAZ Digital Device is the first listed.
NCT05511987 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05511987 about?
NCT05511987 is a clinical study titled "Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients". 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 literatu...
What is the current status of trial NCT05511987?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2023-08-15. Estimated completion is 2025-07-01.
What conditions does trial NCT05511987 study?
This clinical trial studies the following conditions: Air Leakage.
What interventions are being tested in trial NCT05511987?
The interventions under investigation include: Madela THOPAZ Digital Device (DEVICE), Atrium Analog Device (DEVICE).
Who is sponsoring clinical trial NCT05511987?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05511987 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05511987's enrollment target sits among peer trials
140 713th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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