Comparison of Two Different Pleural Drainage Systems

Kerckhoff Klinik

Status: Completed

Conditions: Air Leak From Lung

Treatments: Device: Pleural drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT03021369

Medela1

Details and patient eligibility

About

The digital pleural drainage system Topaz+ by Medela is compared to the analogue system Atrium OCEAN by Maquet in patients undergoing cardiac surgery.

The study is prospectively randomized with an all-comer setup. The patients are randomly selected for one of the systems. The surgery is performed in the standard fashion and chest tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32 French drain is placed in every patient and pericardial and/or pleural drains are optional.

The postoperative course does not vary from the clinical standard and the chest tubes are removed according to institutional standard. The clinical data about fluid amount, time of removal, air leaks, tamponade are routinely collected in a digital patient documentation system.

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients undergoing cardiac surgery
• capability to give informed consent

Exclusion criteria

• no specific exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 2 patient groups

Pleural drainage system Medela

Active Comparator group

Description:

These patients receive the digital Medela system

Treatment:

Device: Pleural drainage system

Pleural drainage system Ocean

Active Comparator group

Description:

These patients receive the analogue Maquet system

Treatment:

Device: Pleural drainage system