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OpenTrials
Completed

NCT Number: NCT05180955

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Klinieken

Zwolle, Overijssel, 8025AB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Recurrent pneumothorax after chest tube removal

    Time frame: 0-24 hours after drain removal

    number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2022
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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