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Digital vs. Analog Chest Drainage Systems for Pediatric Air Leak (THOPAZ Trial)
N/A
Recruiting
Led By Catherine Hunter, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether using a digital chest tube drainage system instead of an analog one has benefits for pediatric patients.
Who is the study for?
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.
What is being tested?
The study compares two types of chest drainage systems: Thopaz+ digital system versus traditional Atrium analog system. It aims to see if the digital system can reduce how long kids need a chest tube, cut down on X-rays needed and shorten air leak duration. This will be done through a randomized controlled trial—the first of its kind for this age group.
What are the potential side effects?
While specific side effects are not detailed here as it's more about device comparison rather than medication side effects; potential risks may include discomfort at the site where the chest tube enters the body and possible infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Atrium Dry Suction Control Water Seal Chest DrainActive Control1 Intervention
there are several limitations to this analog system. First, although the system can manually be set to a certain negative pressure, the actual pressure experienced by the patient varies dependent on the amount of fluid in the tube and the level of the device relative to the patient(2). This leads to inconsistency of pleural pressure which has been associated with an increased incidence of prolonged air leak(2). Second, the analog system relies on a water chamber where bubbles are visualized to indicate an air leak. Air leaks are a common cause of increased duration of chest tube drainage and subsequent length of stay(3). There is high interobserver variability in the subjective measurement of air leaks when using the analog system thus exacerbating the amount of time the chest tube remains in the patient as well as the length of stay(4, 5).
Group II: Madela THOPAZ Suction PumpActive Control1 Intervention
Digital chest tube drainage systems utilize sensors to objectively quantify the size of air leaks as well as adjust the amount of suction applied to the pleural cavity in order to maintain a constant negative pressure(4). Studies in the adult population have showed that using a digital system allows for objective criteria regarding when it is safe to remove the chest tube and thus decreased time of chest tube drainage. This has also translated into decreased length of stay and cost(2, 6-8). Early data suggests that these same benefits may apply to pediatric patients, however a prospective randomized trial comparing the two systems has not been performed(9, 10).
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Who is running the clinical trial?
University of OklahomaLead Sponsor
471 Previous Clinical Trials
93,313 Total Patients Enrolled
Catherine Hunter, MDPrincipal InvestigatorUniversity of Oklahoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 17 years old or younger.I have fluid buildup due to cancer in the lining of my lung.I have had chemotherapy or radiation in the last 12 months.I need a chest tube for a collapsed lung or lung surgery at The Children's Hospital.I am 18 years old or older.My child had a chest tube placed by a specialist.I have an infection in the space around my lungs.I have problems with my nervous system.I have kidney or liver failure.I am scheduled for or have had an emergency surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Atrium Dry Suction Control Water Seal Chest Drain
- Group 2: Madela THOPAZ Suction Pump
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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