Comparison of Two Different Pleural Drainage Systems

Air Leak From Lung Clinical Trial

Official title:

Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021369
• Other study ID #: Medela1
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: February 2020
• Source: Kerckhoff Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients undergoing cardiac surgery

• capability to give informed consent

Exclusion Criteria:

• no specific exclusion criteria

Related Conditions & MeSH terms

• Air Leak From Lung

Intervention

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

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik	Bad Nauheim

Sponsors (1)

Lead Sponsor	Collaborator
Kerckhoff Klinik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	Number of patients with pericardial tamponade that has to be treated by puncture or surgically		Occurrence through hospital stay (an average of 1 week).
Secondary	Number of patients with pleural effusion at discharge echo, without intervention		Occurrence through hospital stay (an average of 1 week).