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

Not Applicable

Completed

• Conditions: Pneumothorax and Air Leak
• Interventions: Other: Digital drainage system; Other: Digital drainage system + clamping trial

• Registration Number: NCT05180955
• Lead Sponsor: Isala

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-18
• Study First Posted: 2022-01-06
• Study Start: 2022-09-16
• Primary Completion: 2024-05-29
• Study Completion: 2024-05-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital drainage system group	Digital drainage system	chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data.
Digital drainage system + clamping trial group	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.

Primary Outcome Measures

Name	Time	Method
Recurrent pneumothorax after chest tube removal	0-24 hours after drain removal	number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax

Trial Locations

Locations (1)

Isala Klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands