Comparison of Two Different Pleural Drainage Systems

Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie

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.

Study Overview

• Status: Completed
• Conditions: Air Leak From Lung
• Intervention / Treatment: Device: Pleural drainage system

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no specific exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pleural drainage system Medela; These patients receive the digital Medela system	Device: Pleural drainage system; Pleural drainage system is connected to the chest tubes after surgery.
Active Comparator: Pleural drainage system Ocean; These patients receive the analogue Maquet system	Device: Pleural drainage system; Pleural drainage system is connected to the chest tubes after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of air leak due to lung leakage or injury during surgery by the pleural drainage system.	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.	Occurrence of air leak is until the drain is removed (usually postoperative day 2 or 3)

Secondary Outcome Measures

Outcome Measure	Time Frame
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).

Collaborators and Investigators

• Sponsor: Kerckhoff Klinik

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 8, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 22, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Medela1