Back to resultsThe Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
Primary Purpose
Pneumothorax and Air Leak
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Digital drainage system
Digital drainage system + clamping trial
Sponsored by
About this trial
This is an interventional treatment trial for Pneumothorax and Air Leak
Eligibility Criteria
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
Sites / Locations
- Isala KliniekenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Digital drainage system group
Digital drainage system + clamping trial group
Arm Description
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.
Outcomes
Primary Outcome Measures
Recurrent pneumothorax after chest tube removal
number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05180955
Brief Title
The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
Official Title
The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax and Air Leak
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital drainage system group
Arm Type
Other
Arm Description
chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data.
Arm Title
Digital drainage system + clamping trial group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Digital drainage system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Digital drainage system + clamping trial
Intervention Description
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 Information:
Title
Recurrent pneumothorax after chest tube removal
Description
number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax
Time Frame
0-24 hours after drain removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wytze de Boer, MD
Phone
+31646312031
Email
w.s.de.boer@isala.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Jos Stigt, MD PhD
Phone
+31384247001
Email
j.a.stigt@isala.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jos Stigt, MD PhD
Organizational Affiliation
Isala
Official's Role
Study Director
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wytze de Boer, MD
Phone
+31646312031
Email
w.s.de.boer@isala.nl
First Name & Middle Initial & Last Name & Degree
Wytze de Boer, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
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