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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2024-05-29

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pneumothorax and Air Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital drainage system group

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

Group Type OTHER

Digital drainage system

Intervention Type 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.

Digital drainage system + clamping trial group

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.

Group Type OTHER

Digital drainage system + clamping trial

Intervention Type 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.

Interventions

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Digital 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.

Intervention Type OTHER

Digital 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No