Digital Chest Tube Drainage System (Thopaz+) Versus Analog in Pediatric Patients

NCT05511987 | Recruiting FDA Device

• 1 other identifier: 14196
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Air Leakage

Keywords

chest tube

Outcome Measures

Primary Outcomes (1)

• The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems.

  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.

  2 years

Study Arms (2)

Madela THOPAZ Suction Pump

ACTIVE COMPARATOR

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).

Device: Madela THOPAZ Digital Device

Atrium Dry Suction Control Water Seal Chest Drain

ACTIVE COMPARATOR

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).

Device: Atrium Analog Device

Interventions

Madela THOPAZ Digital Device DEVICE

Digital drainage systems use electronic sensors to measure changes in pressure and thus may allow for quantification of the degree of air leak continuously and provide a graphical representation of the trend over time. Data on intrapleural pressure are also provided by some units. Together, these data may lead to expedited chest tube removal and hospital discharge with obvious financial implications.

Madela THOPAZ Suction Pump

Atrium Analog Device DEVICE

Analog drainage systems contain a sequentially numbered series of columns in the water seal chamber. The degree of air leak is assessed by observing the highest numbered column in which bubbling occurs. This provides a qualitative assessment at a specific point in time. This assessment, however, is subject to interobserver variability and does not account for variation over time.

Atrium Dry Suction Control Water Seal Chest Drain

Eligibility Criteria

• Age: 0 Minutes - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age≤17 years old
• requiring chest tube placement for spontaneous pneumothorax or pulmonary resection by a surgeon (or surgical trainee) at The Children's Hospital

You may not qualify if:

• age≥18-year-old
• chest tube placement by neonatologist or pediatrician,
• malignant pleural effusion
• re-operation or emergent operation
• pre-operative chemotherapy or radiation or history of chemotherapy or radiation within the past 12 months
• renal or hepatic failure
• neurological dysfunction
• empyema

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (8)

• Munnell ER. Thoracic drainage. Ann Thorac Surg. 1997 May;63(5):1497-502. doi: 10.1016/s0003-4975(97)00082-9.

  PMID: 9146363 BACKGROUND

• Lee SA, Kim JS, Chee HK, Hwang JJ, Ji M, Kim YH, Moon HJ, Lee WS. Clinical application of a digital thoracic drainage system for objectifying and quantifying air leak versus the traditional vacuum system: a retrospective observational study. J Thorac Dis. 2021 Feb;13(2):1020-1035. doi: 10.21037/jtd-20-2993.

  PMID: 33717575 BACKGROUND

• Cerfolio RJ, Varela G, Brunelli A. Digital and smart chest drainage systems to monitor air leaks: the birth of a new era? Thorac Surg Clin. 2010 Aug;20(3):413-20. doi: 10.1016/j.thorsurg.2010.03.007.

  PMID: 20619233 BACKGROUND

• Brunelli A, Salati M, Pompili C, Refai M, Sabbatini A. Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration. Eur J Cardiothorac Surg. 2013 May;43(5):899-904. doi: 10.1093/ejcts/ezs518. Epub 2012 Sep 28.

  PMID: 23024236 BACKGROUND

• Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.

  PMID: 26409729 BACKGROUND

• Jablonski S, Brocki M, Wawrzycki M, Smigielski JA, Kozakiewicz M. Efficacy assessment of the drainage with permanent airflow measurement in the treatment of pneumothorax with air leak. Thorac Cardiovasc Surg. 2014 Sep;62(6):509-15. doi: 10.1055/s-0033-1359714. Epub 2013 Dec 2.

  PMID: 24297633 BACKGROUND

• Costa AD Jr, Bachichi T, Holanda C, Rizzo LA. An initial experience with a digital drainage system during the postoperative period of pediatric thoracic surgery. J Bras Pneumol. 2016 Nov-Dec;42(6):444-446. doi: 10.1590/S1806-37562016000000269.

  PMID: 28117476 BACKGROUND

• Perez-Egido L, Garcia-Casillas MA, Simal I, Fanjul M, Canizo A, Cerda JA, Fernandez B, de la Torre M, Ordonez J, de Agustin JC. Digital thoracic drainage: a new system to monitor air leaks in pediatric population. J Pediatr Surg. 2019 Apr;54(4):693-695. doi: 10.1016/j.jpedsurg.2018.10.068. Epub 2018 Dec 19.

  PMID: 30658842 BACKGROUND

Study Officials

• Catherine Hunter, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Hunter, MD

CONTACT

2718001; catherine-hunter@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: August 23, 2022
• Study Start: August 15, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)