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

Last updated: June 18, 2024
Sponsor: Isala
Overall Status: Completed

Phase

N/A

Condition

Chest Trauma

Treatment

Digital drainage system + clamping trial

Digital drainage system

Clinical Study ID

NCT05180955
Chest Tube Removal 001
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Digital chest tube drainage system

  • Pneumothorax (primary, secondary, pulmonary surgery)

Exclusion

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

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Digital drainage system + clamping trial
Phase:
Study Start date:
September 16, 2022
Estimated Completion Date:
May 29, 2024

Study 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.

Connect with a study center

  • Isala Klinieken

    Zwolle, Overijssel 8025AB
    Netherlands

    Site Not Available

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