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OpenTrials
Completed

NCT Number: NCT03021369

Comparison of Two Different Pleural Drainage Systems

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.

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Key information

Conditions

Air Leak From Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no specific exclusion criteria

Treatment and study plan

Pleural drainage system

Device

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

Primary outcomes

  1. Detection of air leak due to lung leakage or injury during surgery by the pleural drainage system.

    Time frame: Occurrence of air leak is until the drain is removed (usually postoperative day 2 or 3)

    The Thopaz+ system displays the amount of air leak on the screen in ml/min and the Ocean system is a 'wet seal' system, where bubbles in the box might indicate an air leak. If air leak is detected, the train cannot be removed and has to stay until no more air leak is detected. If air leak is unclear, chest x-rays with clamped drains are performed. If an pneumothorax is visible in the x-ray, the drains have to stay, otherwise they can be removed safely. The digital air leak detection and quantification by the Thopaz+ system might help in clearly detecting the air leaks.

Secondary outcomes

  1. Time of chest drain removal

    Time frame: Number of days until the chest drains are removed (usually postoperative day 2 or 3, depending on air leak and amount of fluid).

  2. Fluid amount

    Time frame: Total amount of fluid at the time of chest drain removal (usually postoperative day 2 or 3, depending on air leak and amount of fluid).

  3. Number of patients with pericardial tamponade that has to be treated by puncture or surgically

    Time frame: Occurrence through hospital stay (an average of 1 week).

  4. Number of patients with pleural effusion at discharge echo, without intervention

    Time frame: Occurrence through hospital stay (an average of 1 week).

Sponsors and collaborators

Lead sponsor

Kerckhoff Klinik

Other

Registry information

Official study title

Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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