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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
THOPAZ Trial 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.Check my eligibility
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.See study design
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.
THOPAZ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.
THOPAZ Trial Design
2Treatment groups
Active Control
Group I: 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).
Group II: 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).
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Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,470 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: Madela THOPAZ Suction Pump
- Group 2: Atrium Dry Suction Control Water Seal Chest Drain
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor accept participants who are 18 years of age or older?
"This research is targeting participants between the ages of 0 minutes and 17 years old."
Answered by AI
How many participants are permitted to take part in this medical trial?
"Affirmative. Clinicaltrials.gov has the most up-to-date information, which indicates that this medical trial posted on August 15th 2022 is actively recruiting patients. 140 individuals will be accepted from a single site for study participation."
Answered by AI
Am I suitable to participate in this experiment?
"For this medical trial, 140 participants between 0 minutes and 17 years old with air leakage must be recruited. In addition to the age requirement, all candidates must have undergone chest tube placement for spontaneous pneumothorax or pulmonary resection at The Children's Hospital by a surgeon (or in training)."
Answered by AI
Are volunteers currently being accepted for this experiment?
"Affirmative, the information hosted on clinicaltrials.gov affirms that this trial is actively looking for participants. Initially posted on August 15th 2022 and most recently modified on August 19th 2022, the experiment seeks to recruit 140 individuals from 1 medical centre."
Answered by AI
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