The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.

Isala

Status: Completed

Conditions: Pneumothorax and Air Leak

Treatments: Other: Digital drainage system; Other: Digital drainage system + clamping trial

Study type: Interventional

Funder types: Other

Identifiers

NCT05180955

Chest Tube Removal 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Digital drainage system group

Other group

Description:

chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data.

Treatment:

Other: Digital drainage system

Digital drainage system + clamping trial group

Other group

Description:

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.

Treatment:

Other: Digital drainage system + clamping trial