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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital drainage system group | Other | chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. |
|
| Digital drainage system + clamping trial group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital drainage system | Other | In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data, the tube will not be clamped. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent pneumothorax after chest tube removal | number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax | 0-24 hours after drain removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jos Stigt, MD PhD | Isala | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Klinieken | Zwolle | Overijssel | 8025AB | Netherlands |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
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| Digital drainage system + clamping trial | Other | 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. |
|