Normal VolunteersNCT03993587
The Effect of Head and Shoulder Positioning on the Cross-sectional Area of the Subclavian Vein in Obese Adults
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, and the depth of the SCV from the skin are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) and different shoulder positions (neutral or lowered) in spontaneous breathing obese adults. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Normal Volunteers
- What is being tested?
- Ultrasound assessment of vessels
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Aug 2019to 30 Jun 2020
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Healthy obese adults (BMI ≥ 30)
Who may be able to join
- Healthy obese adults (BMI ≥ 30)
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.
About this study
Official title: The Effect of Head and Shoulder Positioning on the Cross-sectional Area and Location of the Subclavian Vein in Obese Adults
In the present study, the cross-sectional area of subclavian vein, and the depth of the SCV from the skin are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) and different shoulder positions (neutral or lowered) in spontaneous breathing obese adults.
- Conditions
- Normal Volunteers
- Being tested
- Ultrasound assessment of vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of vesselsOther
Subclavian vein and related structures are examined using ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of subclavian vein
Cross-sectional area of subclavian vein is assessed.
Measured: through the completion of assessment, an average of 1 hr
Secondary outcomes (1)
Depth of subclavian vein from skin
Depth of subclavian vein from skin is assessed.
Measured: through the completion of assessment, an average of 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start20 Aug 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 26 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
- Investigators
- Jin-Young Hwang, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993587
- Sponsor's protocol ID
- P2019-192
- Status last verified
- Mar 2021
- First submitted
- 17 Jun 2019
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head and Shoulder Positioning on the Cross-sectional Area and Location of the Subclavian Vein in Obese Adults
- ClinicalTrials.gov ID
- NCT03993587
- Acronym / sponsor ID
- P2019-192
- Conditions
- Normal Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 20 Jun 2019 (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.
In the present study, the cross-sectional area of subclavian vein, and the depth of the SCV from the skin are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) and different shoulder positions (neutral or lowered) in spontaneous breathing obese adults.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy obese adults (BMI ≥ 30)
Key inclusion criteria (1 listed)
- Healthy obese adults (BMI ≥ 30)
Key exclusion criteria (1 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound assessment of vesselsSubclavian vein and related structures are examined using ultrasonography | Other | – |
Primary outcome
Cross-sectional area of subclavian vein
Time frame: through the completion of assessment, an average of 1 hr
Cross-sectional area of subclavian vein is assessed.
1 secondary outcome
Depth of subclavian vein from skin
Time frame: through the completion of assessment, an average of 1 hr
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 29 Mar 2021.
- 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.
Jin-Young Hwang, MD, PhD principal investigator
SMG-SNU Boramae Medical Center
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 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 29 Mar 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 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 the completion of assessment, an average of 1 hr). 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 29 Mar 2021.