Digital vs. Analog Chest Drainage Systems for Pediatric Air Leak

(THOPAZ Trial)

Overseen By Catherine Hunter, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Malignant pleural effusion, Empyema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration varies based on individual patient needs

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares digital and analog chest drainage systems for children with lung air leaks from conditions like spontaneous pneumothorax (a collapsed lung) or post-lung surgery. Researchers aim to determine if the digital system, which uses sensors to measure air leaks and maintain steady pressure, can reduce chest tube duration, the number of chest x-rays, and hospital stay length. Children under 18 who require a chest tube for these conditions at The Children's Hospital may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future treatments for children with lung conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these chest drainage systems are safe for pediatric patients?

Research has shown that digital chest drainage systems, such as the Thopaz+, are generally safe. Studies in adults suggest these systems help remove chest tubes more quickly and shorten hospital stays, indicating their safety. They use sensors to detect air leaks and adjust pressure, maintaining stability and safety.

Analog chest drainage systems lack precise measurement, which can lead to longer drainage times and variability in patient care. However, these systems have been used for a long time and are well-established in the medical field.

Both systems are generally well-tolerated, but the digital system may offer greater safety and comfort due to its precise measurements. So far, no major reports of serious side effects have emerged from either system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing digital and analog chest drainage systems for pediatric air leaks because these systems could potentially improve patient outcomes. The digital system, Thopaz+, stands out because it uses sensors to precisely measure air leaks and maintain constant negative pressure, which could lead to more consistent and quicker recovery times. Unlike traditional analog systems that rely on manual settings and subjective assessments of air leaks, the digital approach offers objective, real-time data that can help doctors decide the optimal time to remove the chest tube, potentially reducing hospital stays and healthcare costs. This trial aims to determine if these benefits seen in adults also apply to children, offering hope for better, more efficient care in pediatric patients.

What evidence suggests that digital chest tube drainage systems are effective for pediatric air leaks?

This trial will compare digital chest tube drainage systems, such as Thopaz+, with traditional analog systems for pediatric air leaks. Research has shown that digital systems can more accurately measure air leaks and maintain steady chest pressure, potentially leading to shorter drainage times and hospital stays. For adults, this also results in fewer chest x-rays and lower costs. Although studies on children are limited, early results suggest they might experience similar benefits. Traditional systems, in contrast, often take longer because they rely on manual pressure settings and personal judgment to assess air leaks. ^{1 2 3 6 7}

Who Is on the Research Team?

Catherine Hunter, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 17 years old or younger.

I need a chest tube for a collapsed lung or lung surgery at The Children's Hospital.

Exclusion Criteria

I have fluid buildup due to cancer in the lining of my lung.

I have had chemotherapy or radiation in the last 12 months.

My child had a chest tube placed by a specialist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the digital (Thopaz+) or analog (Pleur-evac) drainage system and monitored for duration of chest tube drainage, length of stay, and air leaks.

Duration varies based on individual patient needs

Inpatient monitoring

Follow-up

Participants are monitored for safety and effectiveness after chest tube removal, including tracking of complications and recovery progress.

4 weeks

Data Analysis

Interim analysis will be performed once 12 patients per arm are accrued, with continued monitoring until the study is adequately powered.

Ongoing until study completion

What Are the Treatments Tested in This Trial?

Interventions

• Analog Chest Tube Drainage System
• Digital Chest Tube Drainage System (Thopaz+)

Trial Overview 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.

How Is the Trial Designed?

Group I: Atrium Dry Suction Control Water Seal Chest Drain Active Control 1 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 Pump Active Control 1 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).

Analog Chest Tube Drainage System is already approved in European Union, United States for the following indications:

Approved in European Union as Conventional Chest Drainage System for:

• Pulmonary resection
• Pneumothorax
• Thoracic trauma
• Pleural disease

Approved in United States as Traditional Chest Tube Drainage System for:

• Pulmonary resection
• Pneumothorax
• Thoracic trauma
• Pleural disease

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

In a study of 60 patients with primary pneumothorax, the digital chest drainage system significantly reduced the average length of tube drainage to 2.2 days compared to 3.1 days for the conventional system, indicating improved efficacy.

Patients using the digital system reported higher satisfaction rates (about 90%) due to its convenience and real-time monitoring capabilities, suggesting it may enhance patient experience and facilitate better clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of Wi-Fi based digital chest drainage system in the post-operative care of pneumothorax. Cho, HM., Hong, YJ., Byun, CS., et al.[2020]

In a study of 26 pediatric patients undergoing pulmonary resection, the use of a digital thoracic drainage system significantly reduced the duration of chest tube use (1.69 days) compared to traditional drainage (5.38 days), indicating greater efficiency in postoperative care.

The digital system also led to fewer postoperative radiographs (2.8 vs. 6.23), suggesting it may streamline monitoring without compromising safety, as no complications were reported with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital thoracic drainage: a new system to monitor air leaks in pediatric population. Pérez-Egido, L., García-Casillas, MA., Simal, I., et al.[2019]

In a study of 100 patients undergoing decortication for empyema thoracis, the Thopaz™ digital thoracic drain system significantly reduced air leak duration and the length of time chest tubes were needed compared to conventional drains.

Patients using the Thopaz system also had shorter hospital stays and fewer postoperative complications, suggesting it is a safer and more effective option for managing chest drainage after lung surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of thopaz in patients of empyema thoracis undergoing decortication. Alam, MS., Haseen, MA., Aslam, M., et al.[2022]

In a study of 497 patients who underwent lung resection surgery with digital thoracic drainage systems, 35.2% experienced air leak-related complications after chest tube removal, highlighting the need for careful monitoring.

The study identified that a chest drainage duration of five days is a critical threshold for predicting complications and reinterventions, with factors like previous chest surgery and initial air leaks also increasing risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after Chest Tube Removal and Reinterventions in Patients with Digital Drainage Systems. Lee, YY., Hsu, PK., Huang, CS., et al.[2020]

In a study of 17 pediatric patients undergoing thoracoscopic procedures for spontaneous pneumothorax, the use of a digital thoracic drainage system showed no intraoperative complications and allowed for effective management with a median chest tube duration of 4 days.

After adjusting the management approach to include tube clamping when air leaks were less than 5 mL/min for 24 hours, 11 consecutive procedures were completed without complications, suggesting that this method may enhance safety and efficacy in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Thoracic Drainage System: A New Tool For Pediatric Thoracic Surgery. Vasconcelos-Castro, S., Borges-Dias, M., Soares-Oliveira, M.[2023]

Digital drainage systems were trialed as an alternative to traditional chest drainage systems, leading to improved treatment times for patients.

The new digital systems also enhanced patient mobility, suggesting they may offer a safer and more effective option for chest drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of digital thoracic drainage systems. Danitsch, D.[2012]

In a study of 215 patients undergoing lung surgery, digital chest drainage devices did not significantly reduce hospital length of stay or chest tube duration compared to analog devices.

However, the digital devices led to a lower rate of chest tube clamping before removal, with only 19% of patients clamped compared to 47% in the analog group, indicating that digital devices may provide better assessment of air leaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Air Leak Monitoring for Lung Resection Patients: A Randomized Controlled Clinical Trial. Plourde, M., Jad, A., Dorn, P., et al.[2019]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/ppul.71090

Comparative Analysis of Analog and Digital Chest Tube ... This study compares a three-chamber chest drainage system with a digital system using a high-fidelity 3D-printed model.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987057/

Comparative Analysis of Analog and Digital Chest Tube ... This study compares a three‐chamber chest drainage system with a digital system using a high‐fidelity 3D‐printed model.

3. withpower.com withpower.com/trial/early-phase-1-air-leakage-7-2022-44899

Digital vs. Analog Chest Drainage Systems for Pediatric Air ... The investigators hypothesize that pediatric patients who are placed on the Thopaz+ digital drainage system will have decreased duration of chest tube drainage, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003497523002825

Comparison Between Electronic and Traditional Chest ... The aim of this study was to determine whether the use of digital chest drain systems, compared with traditional ones, reduced the duration of chest drainage.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9029690/

Promising Effects of Digital Chest Tube Drainage System ... Conclusions: Digital CTDS is associated with better outcomes than suction and non-suction CTDS for patients undergoing pulmonary resections, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11184673/

Drainology: Leveraging research in chest-drain management ... Three preliminary studies have suggested that digital systems are safe to use in cardiac surgery patients and are associated with reduced air leak, more ...

7. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/08095b7a-962a-48bd-ad5c-10d4d95c0b3a/download

A Systematic Review of Digital Versus Analog Drainage for Air ... 33,37 The mean chest tube duration ranged from 47 to 96 hours with the digital system and from 74 to 94 hours with the analog system. Hospital Length of Stay:.