PneumothoraxTDEANTTNCT02543138
The Development and Experimental Application of a New Thoracostomy Trocar
A study testing Trocar in people with Pneumothorax, run by Hanyang University at 1 site in South Korea.
Trial summary
Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy process that is difficult for unskilled physicians, whereas the use of a traditional trocar is relatively likely to damage internal organs. In this study, investigators developed a new trocar and examined its usefulness. Read more about this study
- Who is it for?
- Ages 25 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Trocar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Aug 2015
- 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 25 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Senior medical students without prior experience with closed thoracostomies
Who cannot join
- Wrist disease, Pregnancy, Do not want to participate
Trial locations and contacts
1 site in 1 country.
About this study
Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy process that is difficult for unskilled physicians, whereas the use of a traditional trocar is relatively likely to damage internal organs. In this study, investigators developed a new trocar and examined its usefulness.
Read the detailed description
The new trocar consists of a mold and a stylet; the mold has a hole in its side to ensure that the chest tube proceeds in only one direction. The mold also has a mark to indicate insertion depth. Sixteen participants without experience with thoracostomies observed one closed thoracostomy procedure using the new trocar and then performed three thoracostomies on a cadaver. For each of these thoracostomies, investigators measured the time required for chest tube insertion, the position of the tip of the chest tube within the thoracic cavity, the difficulty associated with the procedure, and the volunteer's confidence after the procedure.
- Conditions
- Pneumothorax
- Being tested
- Trocar
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrocarDevice
Closed thoracostomy using the new trocar
| Study group | Role | What they receive |
|---|---|---|
| Closed thoracostomy | Experimental | Closed thoracostomy using the new trocar by novice Receives: Device: Trocar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to closed thoracostomy
Measured: 5 minutes
Secondary outcomes (1)
The accuracy of the position of the tip of the chest tube
Yes or No
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionAug 2015
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 PneumothoraxStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YOON-JE, Hanyang University
- Investigators
- YOON-JE LEE, Master, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543138
- Sponsor's protocol ID
- LEE YOON-JE
- Acronym
- TDEANTT
- Status last verified
- Sep 2015
- First submitted
- 14 Aug 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YJ, Choi HJ, Lim TH, Lee SH, Hwang SJ. The development and experimental application of a new thoracostomy trocar. Am J Emerg Med. 2016 May;34(5):917-20. doi: 10.1016/j.ajem.2016.02.016. Epub 2016 Feb 12. No abstract available.
PubMed 26964824
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Experimental Application of a New Thoracostomy Trocar
- ClinicalTrials.gov ID
- NCT02543138
- Acronym / sponsor ID
- TDEANTT / LEE YOON-JE
- Conditions
- Pneumothorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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.
Traditional closed thoracostomy exhibit certain shortcomings. Blind dissection is a lengthy process that is difficult for unskilled physicians, whereas the use of a traditional trocar is relatively likely to damage internal organs. In this study, investigators developed a new trocar and examined its usefulness.
Detailed description
The new trocar consists of a mold and a stylet; the mold has a hole in its side to ensure that the chest tube proceeds in only one direction. The mold also has a mark to indicate insertion depth. Sixteen participants without experience with thoracostomies observed one closed thoracostomy procedure using the new trocar and then performed three thoracostomies on a cadaver. For each of these thoracostomies, investigators measured the time required for chest tube insertion, the position of the tip of the chest tube within the thoracic cavity, the difficulty associated with the procedure, and the volunteer's confidence after the procedure.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed thoracostomy | Experimental | Device: TrocarClosed thoracostomy using the new trocar by novice |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Senior medical students without prior experience with closed thoracostomies
Key exclusion criteria (1 listed)
- Wrist disease, Pregnancy, Do not want to participate
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 |
|---|---|---|
| TrocarClosed thoracostomy using the new trocar | Device | Closed thoracostomy |
Primary outcome
Time to closed thoracostomy
Time frame: 5 minutes
1 secondary outcome
The accuracy of the position of the tip of the chest tube
Time frame: 5 minutes
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 7 Sep 2015.
- Derived from this study: PubMed 26964824Lee YJ, Choi HJ, Lim TH, Lee SH, Hwang SJ. The development and experimental application of a new thoracostomy trocar. Am J Emerg Med. 2016 May;34(5):917-20. doi: 10.1016/j.ajem.2016.02.016. Epub 2016 Feb 12. No abstract available.
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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.
YOON-JE LEE, Master principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trocar in people with Pneumothorax, run by Hanyang University at 1 site in South Korea.
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 1 inclusion and 1 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 7 Sep 2015. 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 South Korea. 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?
Time to closed thoracostomy (time frame: 5 minutes). 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 NCT02543138, 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 7 Sep 2015.