Catheterization, Central Venous; UltrasonographyNCT03481062
Anatomy and Ultrasound Evaluation for Central Venous Access
An observational study of Catheterization, Central Venous; Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The anatomy and ultrasound image of subclavian vein was investigated on cadavers, volunteers and patients, respectively. Structures，approach，position and complications were discussed to improve the success rate and safety of central venous catheterization. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheterization, Central Venous; Ultrasonography
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 30 Dec 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult Asian without past medical history of the infraclavicular region
Who may be able to join
- 18-65 years old
- gender unlimited
- 18.5 < body mass index (BMI) < 30
- written consent signed.
Who cannot join
- abnormality of the infraclavicular region, including infection, deformity,
- history of bone, joint, muscle or neurovascular disease
- history of injury, radiation or invasive procedure
- subjects refused.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jin Wang, MD, ＋86 15210424157, wangjin05@163.com
About this study
Official title: Optimisation of Subclavian Venous Catheterization
The anatomy and ultrasound image of subclavian vein was investigated on cadavers, volunteers and patients, respectively. Structures，approach，position and complications were discussed to improve the success rate and safety of central venous catheterization.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neutral | Not described | |
| abduction | Not described | |
| pad | Not described | |
| combination | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
area
SV area in square centimeter
Measured: 12 months
length
SV length in centimeter
Measured: 12 months
Secondary outcomes (3)
width
SV width in centimeter
Measured: 12 months
skin distance
depth from skin in centimeter
Measured: 12 months
comfort
comfort level rated by Likert scale ranged point 1 to 5, indicating increased comfort level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Mar 2018
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, Central Venous; UltrasonographyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481062
- Sponsor's protocol ID
- OSCAR
- Status last verified
- Oct 2018
- First submitted
- 22 Mar 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Subclavian Venous Catheterization
- ClinicalTrials.gov ID
- NCT03481062
- Acronym / sponsor ID
- OSCAR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 29 Mar 2018 (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.
The anatomy and ultrasound image of subclavian vein was investigated on cadavers, volunteers and patients, respectively. Structures，approach，position and complications were discussed to improve the success rate and safety of central venous catheterization.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neutral | – | – |
| abduction | – | – |
| pad | – | – |
| combination | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult Asian without past medical history of the infraclavicular region
Key inclusion criteria (4 listed)
- 18-65 years old
- gender unlimited
- 18.5 < body mass index (BMI) < 30
- written consent signed.
Key exclusion criteria (4 listed)
- abnormality of the infraclavicular region, including infection, deformity,
- history of bone, joint, muscle or neurovascular disease
- history of injury, radiation or invasive procedure
- subjects refused.
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
area
Time frame: 12 months
SV area in square centimeter
length
Time frame: 12 months
SV length in centimeter
3 secondary outcomes
width
Time frame: 12 months
skin distance
Time frame: 12 months
comfort
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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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.
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 Catheterization, Central Venous; Ultrasonography, run by Peking Union Medical College Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Oct 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area (time frame: 12 months). The study lists 2 primary outcomes in all. 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 Oct 2018.