Iatrogenic PneumothoraxNCT03724721
Pneumothorax Drainage With Vacuum Bottle
A study testing vacuum bottle in people with Iatrogenic Pneumothorax and Vacuum Bottle Assisted Needle Aspiration, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Iatrogenic Pneumothorax, Vacuum Bottle Assisted Needle Aspiration
- What is being tested?
- vacuum bottle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Aug 2018to 1 Mar 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion criteria:
- Clinical diagnosis of pneumothorax
- Exclusion criteria
- Bleeding tendency
- Tension pneumothorax
- Shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax
The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.
Read the detailed description
For aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. A 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. Vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. However, the use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.
- Being tested
- vacuum bottle
- Keywords
- Pneumothorax/therapy, Drainage
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum bottleProcedure or surgery
using vacuum bottle plus catheter for drainage of pneumothorax
| Study group | Role | What they receive |
|---|---|---|
| pneumothorax drainage | Experimental | Pneumothorax drainage with vacuum bottle plus intercostal catheter Receives: Procedure: vacuum bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapleural pressure during vacuum bottle air drainage
The investigator will measure the intrapleural pressure during air drainage at 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and until finished (the remaining with 5 minutes interval). It is proposed in previous studies that it is safe if the intrapleural pressure is less than 20 cmH2O during the procedure.
Measured: Within 1 hour
Secondary outcomes (2)
Rate of reexpansion pulmonary edema
By calculating the rate of reexpansion pulmonary edema among vacuum bottle assisted drainage can investigator determine whether it is a safe procedure
Measured: within 1day after the procedure
The resolution rate of pneumothorax
Chest X ray will be taken after the procedure and compared with that taken before the procedure. By using Rhea method, the investigator can compare the percentage of remaining pneumothorax compared with that before the procedure.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start23 Aug 2018
- Primary completion11 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic PneumothoraxStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuo Yao-Wen, MD, Principal investigator, National Taiwan University HospitalChen Shih-Yu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724721
- Sponsor's protocol ID
- 201805105DINA
- Status last verified
- Jan 2021
- First submitted
- 16 Oct 2018
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen SY, Kuo YW, Ho CC, Wu HD, Wang HC. Safety and efficacy of vacuum bottle plus catheter for drainage of iatrogenic pneumothorax. BMC Pulm Med. 2022 Jun 7;22(1):221. doi: 10.1186/s12890-022-02009-8.
PubMed 35672758
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Pneumothorax
- ClinicalTrials.gov ID
- NCT03724721
- Acronym / sponsor ID
- 201805105DINA
- Keywords
- Pneumothorax/therapy, Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Oct 2018 (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 use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.
Detailed description
For aspiration or drainage of pneumothorax, a 16-gauge or 18-gauge over-the-needle non-tunneled catheter, a pigtail, or chest tube are frequently used to penetrate the pleural space. A 50-ml or 60-ml syringe may be connected to the over-the-needle catheter or a pigtail for simple aspiration, while underwater-sealed bottle or suction drainage connected to chest tube for drainage of pneumothorax. Vacuum bottle for removing pleural effusion are frequently reported in literature and common in daily practice. However, the use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pneumothorax drainage | Experimental | Procedure: vacuum bottlePneumothorax drainage with vacuum bottle plus intercostal catheter |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| vacuum bottleusing vacuum bottle plus catheter for drainage of pneumothorax | Procedure or surgery | pneumothorax drainage |
Primary outcome
Intrapleural pressure during vacuum bottle air drainage
Time frame: Within 1 hour
The investigator will measure the intrapleural pressure during air drainage at 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and until finished (the remaining with 5 minutes interval). It is proposed in previous studies that it is safe if the intrapleural pressure is less than 20 cmH2O during the procedure.
2 secondary outcomes
Rate of reexpansion pulmonary edema
Time frame: within 1day after the procedure
The resolution rate of pneumothorax
Time frame: 1 week
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 12 Jan 2021.
- Derived from this study: PubMed 35672758Chen SY, Kuo YW, Ho CC, Wu HD, Wang HC. Safety and efficacy of vacuum bottle plus catheter for drainage of iatrogenic pneumothorax. BMC Pulm Med. 2022 Jun 7;22(1):221. doi: 10.1186/s12890-022-02009-8.
Related trials for Iatrogenic Pneumothorax
Not yet recruitingObservational study
Clinical Value of Routine Chest Radiography and Point-of-Care Lung Ultrasound Following Ambulatory Thoracic Sympathectomy
Pneumothorax Iatrogenic Postprocedural
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.
Kuo Yao-Wen, MD principal investigator
National Taiwan University Hospital
Chen Shih-Yu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vacuum bottle in people with Iatrogenic Pneumothorax and Vacuum Bottle Assisted Needle Aspiration, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Jan 2021. 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 Taiwan. 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?
Intrapleural pressure during vacuum bottle air drainage (time frame: Within 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724721, which also lists 1 linked publication.
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 12 Jan 2021.