Normal VolunteersNCT02860351
The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein.
An observational study of Normal Volunteers, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
In the present study, the cross-sectional area of subclavian vein, the distances of subclavian vein ~ subclavian artery and subclavian vein ~ pleura are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous breathing adults. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Volunteers
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2016to 10 Mar 2017
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults ≥ 20 yr
Who may be able to join
- Healthy adults
Who cannot join
- Medication affecting vascular elasticity
- History of central venous catheterization or clavicle fracture
- History of lung surgery, operation of chest cage
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein
In the present study, the cross-sectional area of subclavian vein, the distances of subclavian vein ~ subclavian artery and subclavian vein ~ pleura are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous breathing adults.
- Conditions
- Normal Volunteers
- Keywords
- subclavian vein
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of subclavian vein
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
depth of subclavian vein from skin
Measured: through study completion, an average of 1 year
Distance of subclavian vein ~ subclavian artery
Measured: through study completion, an average of 1 year
Distance of subclavian vein ~ pleura
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
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 Normal VolunteersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860351
- Sponsor's protocol ID
- PRE20160711-001
- Status last verified
- Apr 2017
- First submitted
- 28 Jul 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim H, Chang JE, Lee JM, Han SH, Ryu JH, Hwang JY. The Effect of Head Position on the Cross-Sectional Area of the Subclavian Vein. Anesth Analg. 2018 Jun;126(6):1946-1948. doi: 10.1213/ANE.0000000000002446.
PubMed 28863021
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein
- ClinicalTrials.gov ID
- NCT02860351
- Acronym / sponsor ID
- PRE20160711-001
- Conditions
- Normal Volunteers
- Keywords
- subclavian vein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2016
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 9 Aug 2016 (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.
In the present study, the cross-sectional area of subclavian vein, the distances of subclavian vein ~ subclavian artery and subclavian vein ~ pleura are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous breathing adults.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults ≥ 20 yr
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (3 listed)
- Medication affecting vascular elasticity
- History of central venous catheterization or clavicle fracture
- History of lung surgery, operation of chest cage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-sectional area of subclavian vein
Time frame: through study completion, an average of 1 year
3 secondary outcomes
depth of subclavian vein from skin
Time frame: through study completion, an average of 1 year
Distance of subclavian vein ~ subclavian artery
Time frame: through study completion, an average of 1 year
Distance of subclavian vein ~ pleura
Time frame: through study completion, an average of 1 year
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 10 Apr 2017.
- Derived from this study: PubMed 28863021Kim H, Chang JE, Lee JM, Han SH, Ryu JH, Hwang JY. The Effect of Head Position on the Cross-Sectional Area of the Subclavian Vein. Anesth Analg. 2018 Jun;126(6):1946-1948. doi: 10.1213/ANE.0000000000002446.
- Individual participant dataSharing planned: No
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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?
An observational study of Normal Volunteers, run by SMG-SNU Boramae Medical Center 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 3 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 10 Apr 2017. 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?
Cross-sectional area of subclavian vein (time frame: through study completion, an average of 1 year). 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 NCT02860351, 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 10 Apr 2017.