Pediatric Subclavian Vein CatheterizationSCVLDNCT01608503
Lung Deflation in Pediatric Subclavian Vein Catheterization
A study testing lung deflation and lung inflation in people with Pediatric Subclavian Vein Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Pediatric Subclavian Vein Catheterization
- What is being tested?
- lung deflation and lung inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Apr 2012
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients who were scheduled for elective operation under general anesthesia
- Neonates (0 ~ 1 mo), Infants (1 mo ~ 1 yr)
Who cannot join
- Structural anomalies of the chest wall
- History of lung and chest wall operations
- Prior central venous catheterization
- Upper respiratory tract infection, or pneumonia within 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lung Deflation on the Position of the Pleura in Mechanically Ventilated Infants During Subclavian Vein Cannulation: an Ultrasound Study
The subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. The investigators evaluated the effect of lung deflation on the relative position between the pleura and the line of the imaginary needle pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV) using ultrasonography.
- Being tested
- lung deflation, lung inflation
- Keywords
- subclavian vein, ultrasound, distance between the subclavian vein and the lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung deflationProcedure or surgery
lung was deflated during respiration cycle
lung inflationProcedure or surgery
lung was inflated during respiratory cycle
| Study group | Role | What they receive |
|---|---|---|
| respiration cycle | Experimental | lung inflation and deflation Receives: Procedure: lung deflation; Procedure: lung inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance between the pleura and the line of the imaginary needle pathway (DPI)
The ultra-sonography probe was adjusted to obtain an image containing the long-axis cross section of SCV, the pleura, the clavicle, and the first rib. Images were recorded by the same physician during whole respiratory cycle with the probe held in the identical position.
Imaginary lines for supraclavicular and infraclavicular approach were drawn, and distances from the pleura were measured.
If the pleura touched the INP, the distance was recorded as positive value. If the pleura did not touch the INP, the distance was recorded as negative value.
Measured: Within 5 minutes
Secondary outcomes (1)
The incidence of pleural movement over the imaginary needle pathway
If the pleura touched the imaginary needle pathway, the incidence was checked.
Measured: Within 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608503
- Sponsor's protocol ID
- SVCLungDown
- Acronym
- SCVLD
- Status last verified
- Apr 2013
- First submitted
- 26 May 2012
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lung Deflation on the Position of the Pleura in Mechanically Ventilated Infants During Subclavian Vein Cannulation: an Ultrasound Study
- ClinicalTrials.gov ID
- NCT01608503
- Acronym / sponsor ID
- SCVLD / SVCLungDown
- Keywords
- subclavian vein, ultrasound, distance between the subclavian vein and the lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 31 May 2012 (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 subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. The investigators evaluated the effect of lung deflation on the relative position between the pleura and the line of the imaginary needle pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV) using ultrasonography.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| respiration cycle | Experimental | Procedure: lung deflation, Procedure: lung inflationlung inflation and deflation |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients who were scheduled for elective operation under general anesthesia
- Neonates (0 ~ 1 mo), Infants (1 mo ~ 1 yr)
Key exclusion criteria (4 listed)
- Structural anomalies of the chest wall
- History of lung and chest wall operations
- Prior central venous catheterization
- Upper respiratory tract infection, or pneumonia within 2 weeks
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 |
|---|---|---|
| lung deflationlung was deflated during respiration cycle | Procedure or surgery | respiration cycle |
| lung inflationlung was inflated during respiratory cycle | Procedure or surgery | respiration cycle |
Primary outcome
The distance between the pleura and the line of the imaginary needle pathway (DPI)
Time frame: Within 5 minutes
The ultra-sonography probe was adjusted to obtain an image containing the long-axis cross section of SCV, the pleura, the clavicle, and the first rib. Images were recorded by the same physician during whole respiratory cycle with the probe held in the identical position. Imaginary lines for supraclavicular and infraclavicular approach were drawn, and distances from the pleura were measured. If the pleura touched the INP, the distance was recorded as positive value. If the pleura did not touch the INP, the distance was recorded as negative value.
1 secondary outcome
The incidence of pleural movement over the imaginary needle pathway
Time frame: Within 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 23 Apr 2013.
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 lung deflation and lung inflation in people with Pediatric 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 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 23 Apr 2013. 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?
The distance between the pleura and the line of the imaginary needle pathway (DPI) (time frame: Within 5 minutes). 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 23 Apr 2013.