Subclavian Vein CatheterizationNCT01815801
Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization
A study testing Lungs were not mechanically ventilated during subclavian vein catheterization and Lungs were mechanically ventilated during subclavian vein catheterization in people with Subclavian Vein Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Subclavian Vein Catheterization
- What is being tested?
- Lungs were not mechanically ventilated during subclavian vein catheterization and Lungs were mechanically ventilated during subclavian vein catheterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Mar 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization
Who cannot join
- infection over the puncture site
- history of prior clavicular fracture
- anatomical anomaly of subclavian vein
- Pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.
- Conditions
- Subclavian Vein Catheterization
- Being tested
- Lungs were not mechanically ventilated during subclavian vein catheterization, Lungs were mechanically ventilated during subclavian vein catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lungs were not mechanically ventilated during subclavian vein catheterizationOther
Control group
Lungs were mechanically ventilated during subclavian vein catheterizationOther
Ventilated group
| Study group | Role | What they receive |
|---|---|---|
| Ventilated group | Experimental | Lungs were mechanically ventilated during subclavian vein catheterization. Receives: Other: Lungs were mechanically ventilated during subclavian vein catheterization |
| Control group | Active comparator | Lungs were not mechanically ventilated during subclavian vein catheterization. Receives: Other: Lungs were not mechanically ventilated during subclavian vein catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of pneumothorax
Postoperative chest X-ray will be taken to check for the occurence of pneumothorax.
Measured: an expected average of one day after surgery
Secondary outcomes (1)
catheterization success rate
Measured: an expected average of one day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclavian Vein CatheterizationStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815801
- Sponsor's protocol ID
- H-1301-066-459
- Status last verified
- Apr 2016
- First submitted
- 19 Mar 2013
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization
- ClinicalTrials.gov ID
- NCT01815801
- Acronym / sponsor ID
- H-1301-066-459
- Conditions
- Subclavian Vein Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Mar 2013 (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.
The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilated group | Experimental | Other: Lungs were mechanically ventilated during subclavian vein catheterizationLungs were mechanically ventilated during subclavian vein catheterization. |
| Control group | Active comparator | Other: Lungs were not mechanically ventilated during subclavian vein catheterizationLungs were not mechanically ventilated during subclavian vein catheterization. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization
Key exclusion criteria (4 listed)
- infection over the puncture site
- history of prior clavicular fracture
- anatomical anomaly of subclavian vein
- Pneumothorax
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 |
|---|---|---|
| Lungs were not mechanically ventilated during subclavian vein catheterizationControl group | Other | Control group |
| Lungs were mechanically ventilated during subclavian vein catheterizationVentilated group | Other | Ventilated group |
Primary outcome
incidence of pneumothorax
Time frame: an expected average of one day after surgery
Postoperative chest X-ray will be taken to check for the occurence of pneumothorax.
1 secondary outcome
catheterization success rate
Time frame: an expected average of one day after surgery
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 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lungs were not mechanically ventilated during subclavian vein catheterization and Lungs were mechanically ventilated during subclavian vein catheterization in people with Subclavian Vein Catheterization, run by Seoul National University Hospital 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 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 Apr 2016. 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?
incidence of pneumothorax (time frame: an expected average of one day after surgery). 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 Apr 2016.