Comparison of Two Different Pleural Drainage Systems

Not Applicable

Completed

• Conditions: Air Leak From Lung
• Interventions: Device: Pleural drainage system

• Registration Number: NCT03021369
• Lead Sponsor: Kerckhoff Klinik

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-22
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

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

Exclusion Criteria

• no specific exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pleural drainage system Medela	Pleural drainage system	These patients receive the digital Medela system
Pleural drainage system Ocean	Pleural drainage system	These patients receive the analogue Maquet system

Primary Outcome Measures

Name	Time	Method
Detection of air leak due to lung leakage or injury during surgery by the pleural drainage system.	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 Outcome Measures

Name	Time	Method
Time of chest drain removal	Number of days until the chest drains are removed (usually postoperative day 2 or 3, depending on air leak and amount of fluid).
Fluid amount	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).
Number of patients with pericardial tamponade that has to be treated by puncture or surgically	Occurrence through hospital stay (an average of 1 week).
Number of patients with pleural effusion at discharge echo, without intervention	Occurrence through hospital stay (an average of 1 week).

Trial Locations

Locations (1)

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany