Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05180955 |
Other study ID # |
Chest Tube Removal 001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 16, 2022 |
Est. completion date |
May 29, 2024 |
Study information
Verified date |
June 2024 |
Source |
Isala |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study will be conducted as a, prospective, open label, non-inferiority, randomized
controlled trial. In the intervention group; chest tube removal will be determined by air
flow criteria as indicated by the digital drainage system data. In the control group removal
will be determined by the same criteria of the digital drainage system but before removal, a
chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax
after chest tube removal requiring chest tube reinsertion
Description:
Determining and timing of chest tube removal has been a continuous topic of debate amongst
both surgeons and pulmonologist. It is plausible that provocative clamping tests are no
longer necessary when a digital continuous recording drainage device is used that
demonstrates the absence of (intermittent) air leak. However, clamping trials are still
performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent
pneumothorax and no comparative studies exist. We hypothesize that chest tube removal
exclusively based on digital drainage system data is as safe as adding a clamping test before
removal in patients treated for pneumothorax or after lung surgery.
The study will be conducted as a, prospective, open label, non-inferiority, randomized
controlled trial. In the intervention group; chest tube removal will be determined by air
flow criteria as indicated by the digital drainage system data. In the control group removal
will be determined by the same criteria of the digital drainage system but before removal, a
chest tube clamping test will be performed.