Air Leak From LungNCT03021369
Comparison of Two Different Pleural Drainage Systems
A study testing Pleural drainage system in people with Air Leak From Lung, run by Kerckhoff Klinik at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung
- What is being tested?
- Pleural drainage system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing cardiac surgery
- capability to give informed consent
Who cannot join
- no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Air Leak From Lung
- Being tested
- Pleural drainage system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural drainage systemDevice
Pleural drainage system is connected to the chest tubes after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pleural drainage system Medela | Active comparator | These patients receive the digital Medela system Receives: Device: Pleural drainage system |
| Pleural drainage system Ocean | Active comparator | These patients receive the analogue Maquet system Receives: Device: Pleural drainage system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Occurrence of air leak is until the drain is removed (usually postoperative day 2 or 3)
Secondary outcomes (4)
Time of chest drain removal
Measured: 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
Measured: 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
Measured: Occurrence through hospital stay (an average of 1 week).
Number of patients with pleural effusion at discharge echo, without intervention
Measured: Occurrence through hospital stay (an average of 1 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerckhoff Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021369
- Sponsor's protocol ID
- Medela1
- Status last verified
- Feb 2020
- First submitted
- 8 Jan 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie
- ClinicalTrials.gov ID
- NCT03021369
- Acronym / sponsor ID
- Medela1
- Conditions
- Air Leak From Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Kerckhoff KlinikUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleural drainage system Medela | Active comparator | Device: Pleural drainage systemThese patients receive the digital Medela system |
| Pleural drainage system Ocean | Active comparator | Device: Pleural drainage systemThese patients receive the analogue Maquet system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients undergoing cardiac surgery
- capability to give informed consent
Key exclusion criteria (1 listed)
- no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural drainage systemPleural drainage system is connected to the chest tubes after surgery. | Device | Pleural drainage system Medela, Pleural drainage system Ocean |
Primary outcome
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.
4 secondary outcomes
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).
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).
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).
Number of patients with pleural effusion at discharge echo, without intervention
Time frame: Occurrence through hospital stay (an average of 1 week).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleural drainage system in people with Air Leak From Lung, run by Kerckhoff Klinik at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.