Recruiting

Thopaz+ vs. Analog

Sponsor:

University of Oklahoma

Code:

NCT05511987

Conditions

Air Leakage

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Madela THOPAZ Digital Device

Atrium Analog Device

Study Details

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

Study ID

NCT05511987

Start date

Aug 15, 2023

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Madela THOPAZ Suction Pump

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).

active comparator: Atrium Dry Suction Control Water Seal Chest Drain

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).

Interventions

Madela THOPAZ Digital 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.

Atrium Analog 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.

Primary outcome measure

  • The THOPAZ digital device vs the Atrium Dry Suction Control Water Seal analog chest tube drainage systems. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Catherine Hunter, MD

2718001catherine-hunter@ouhsc.edu

Locations

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Catherine Hunter, MD

405-271-8001catherine-hunter@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • chest tube

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-04-01.