Comparison of Two Different Pleural Drainage Systems

NCT03021369 | Completed

• 1 other identifier: Medela1
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Air Leak From Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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).

Study Arms (2)

Pleural drainage system Medela

ACTIVE COMPARATOR

These patients receive the digital Medela system

Device: Pleural drainage system

Pleural drainage system Ocean

ACTIVE COMPARATOR

These patients receive the analogue Maquet system

Device: Pleural drainage system

Interventions

Pleural drainage system DEVICE

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

Pleural drainage system Medela; Pleural drainage system Ocean

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Kerckhoff Klinik: lead

Study Sites (1)

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: January 13, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

DE (1)