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

ConditionAir Leakage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorUniversity of Oklahoma

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

age≥18-year-old

chest tube placement by neonatologist or pediatrician,

malignant pleural effusion

re-operation or emergent operation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Madela THOPAZ Suction PumpActive comparator 1 intervention
Group B: Atrium Dry Suction Control Water Seal Chest DrainActive comparator 1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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