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

Study Overview

• Status: Recruiting
• Conditions: Pneumothorax and Air Leak
• Intervention / Treatment: Other: Digital drainage system; Other: Digital drainage system + clamping trial

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 Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jos Stigt, MD PhD; Phone Number: +31384247001; Email: j.a.stigt@isala.nl
• Study Contact Backup: Name: Wytze de Boer, MD; Phone Number: +31646312031; Email: w.s.de.boer@isala.nl

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025AB
      • Recruiting
      • Isala Klinieken
      • Contact: Wytze de Boer, MD; Phone Number: +31646312031; Email: w.s.de.boer@isala.nl
      • Principal Investigator: Wytze de Boer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Digital drainage system group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Isala
• Investigators: Study Director: Jos Stigt, MD PhD, Isala

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 18, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: Chest Tube Removal 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No