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

Trial Summary

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 data supports the effectiveness of the treatment Digital Chest Tube Drainage System (Thopaz+) for pediatric air leak?

Research shows that digital chest drainage systems, like Thopaz+, improve treatment time and patient mobility compared to traditional systems. They also provide objective measurements and reduce variability in patient care, which can be beneficial in managing air leaks. ^{1 2 3 4 5}

Is the digital chest drainage system safe for use in children?

Digital chest drainage systems have been used safely in adults and are being explored for use in children, with some studies suggesting they may improve treatment time and patient mobility compared to traditional systems. However, there is limited experience and data specifically in the pediatric population, so more research is needed to fully understand their safety in children. ^{1 2 4 5 6}

How does the digital chest drainage system differ from traditional treatments for pediatric air leaks?

The digital chest drainage system, like Thopaz+, offers objective measurements of air leaks and allows for remote monitoring, which can improve decision-making about when to remove chest tubes and enhance patient mobility compared to traditional systems that rely on subjective assessments. ^{1 2 3 5 7}

What is the purpose of this trial?

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.

Research Team

Catherine Hunter, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Benefits of digital thoracic drainage systems. [2012]

2. Portugal pubmed.ncbi.nlm.nih.gov

Digital Thoracic Drainage System: A New Tool For Pediatric Thoracic Surgery. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Digital Air Leak Monitoring for Lung Resection Patients: A Randomized Controlled Clinical Trial. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Use of thopaz in patients of empyema thoracis undergoing decortication. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Digital thoracic drainage: a new system to monitor air leaks in pediatric population. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Complications after Chest Tube Removal and Reinterventions in Patients with Digital Drainage Systems. [2020]

7. China pubmed.ncbi.nlm.nih.gov

The usefulness of Wi-Fi based digital chest drainage system in the post-operative care of pneumothorax. [2020]