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

Conditions

• Air Leakage

Eligibility Criteria

Sex

ALL

Age

0 Minutes - 17 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 15, 2023

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Dec 1, 2027

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

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).

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

• Catherine Hunter, MD
  2718001
  [email protected]

Locations (1)

Find similar trials in Oklahoma City, OK