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

Pneumothorax and Air Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180955
• Other study ID #: Chest Tube Removal 001
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: Isala
• Contact: Wytze de Boer, MD
• Phone: +31646312031
• Email: w.s.de.boer[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax
• Pneumothorax and Air Leak

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent pneumothorax after chest tube removal	number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax	0-24 hours after drain removal