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

NCT05180955 | Completed DMC

• 1 other identifier: Chest Tube Removal 001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Pneumothorax and Air Leak

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Digital drainage system group

OTHER

chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data.

Other: Digital drainage system

Digital drainage system + clamping trial group

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.

Other: Digital drainage system + clamping trial

Interventions

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 group

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.

Digital drainage system + clamping trial group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Digital chest tube drainage system
• Pneumothorax (primary, secondary, pulmonary surgery)

You may not qualify if:

• Pleural effusion as primary indication for chest tube placement.
• Empyema
• Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
• Intubated during chest tube removal

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8025AB, Netherlands

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Jos Stigt, MD PhD

  Isala

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 6, 2022
• Study Start: September 16, 2022
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)