Pneumothorax and Air LeakNCT05180955
The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
A study testing Digital drainage system and Digital drainage system + clamping trial in people with Pneumothorax and Air Leak, run by Isala at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax and Air Leak
- What is being tested?
- Digital drainage system and Digital drainage system + clamping trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Sep 2022to 29 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Digital chest tube drainage system
- Pneumothorax (primary, secondary, pulmonary surgery)
Who cannot join
- Pleural effusion as primary indication for chest tube placement.
- Empyema
- Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
- Intubated during chest tube removal
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Pneumothorax and Air Leak
- Being tested
- Digital drainage system, Digital drainage system + clamping trial
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital drainage systemOther
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 trialOther
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 group | Role | What they receive |
|---|---|---|
| Digital drainage system group | Other | chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. Receives: 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. Receives: Other: Digital drainage system + clamping trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent pneumothorax after chest tube removal
number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax
Measured: 0-24 hours after drain removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start16 Sep 2022
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax and Air LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wytze de Boer, Isala
- Investigators
- Jos Stigt, MD PhD, Study director, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180955
- Sponsor's protocol ID
- Chest Tube Removal 001
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.
- ClinicalTrials.gov ID
- NCT05180955
- Acronym / sponsor ID
- Chest Tube Removal 001
- Conditions
- Pneumothorax and Air Leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Digital drainage system group | Other | Other: Digital drainage systemchest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. |
| Digital drainage system + clamping trial group | Other | Other: Digital drainage system + clamping trialIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Digital chest tube drainage system
- Pneumothorax (primary, secondary, pulmonary surgery)
Key exclusion criteria (4 listed)
- Pleural effusion as primary indication for chest tube placement.
- Empyema
- Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
- Intubated during chest tube removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital drainage systemIn 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 group |
| Digital drainage system + clamping trialIn 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 group |
Primary outcome
Recurrent pneumothorax after chest tube removal
Time frame: 0-24 hours after drain removal
number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Pneumothorax and Air Leak
Recruiting
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Air Leak From Lung, Pneumothorax
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jos Stigt, MD PhD study director
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital drainage system and Digital drainage system + clamping trial in people with Pneumothorax and Air Leak, run by Isala at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent pneumothorax after chest tube removal (time frame: 0-24 hours after drain removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.