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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03021369 |
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Date of registration:
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08/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Two Different Pleural Drainage Systems
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Scientific title:
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Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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374 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03021369 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients undergoing cardiac surgery
- capability to give informed consent
Exclusion Criteria:
- no specific exclusion criteria
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Air Leak From Lung
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Intervention(s)
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Device: Pleural drainage system
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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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).]
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Number of patients with pleural effusion at discharge echo, without intervention
[Time Frame: Occurrence through hospital stay (an average of 1 week).]
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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).]
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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).]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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