Pneumothorax and Air Leak
Conditions
Brief 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
Detailed 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.
Interventions
OTHERDigital drainage system
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.
OTHERDigital drainage system + clamping trial
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.
Sponsors
Isala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Digital chest tube drainage system * Pneumothorax (primary, secondary, pulmonary surgery)
Exclusion criteria
* Pleural effusion as primary indication for chest tube placement. * Empyema * Suspected chest tube malfunction (e.g., leaking, occlusion, malposition) * Intubated during chest tube removal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent pneumothorax after chest tube removal | 0-24 hours after drain removal | number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax |
Countries
Netherlands
Outcome results
None listed