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Comparison of Two Different Pleural Drainage Systems

NCT03021369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2020-02-25

No results posted yet for this study

Summary

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.

Conditions

  • Air Leak From Lung

Interventions

DEVICE

Pleural drainage system

Pleural drainage system is connected to the chest tubes after surgery.

Sponsors & Collaborators

  • Kerckhoff Klinik

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03021369 on ClinicalTrials.gov