Central Venous CatheterizationNCT04916288
Needle Puncture Point During Central Venous Catheterization With Ultrasound Guidance
An observational study of Central Venous Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this observational study, we will measure the shortest distance from the cricoid cartilage level to the puncture site of the introducer needle when anesthesiologists perform central venous catheterization. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- central venous cathterization
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2021to 16 Aug 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>18 years old) scheduled to elective surgery requiring central venous catheterization under general anesthesia.
Who may be able to join
- elective surgery under general anesthesia
- requirement of central venous catheterization
Who cannot join
- disagreement for participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061
About this study
Official title: Position of Puncture Point of the Introducer Needle During Internal Jugular Venous Catheterization With Ultrasound Guidance
In this observational study, we will measure the shortest distance from the cricoid cartilage level to the puncture site of the introducer needle when anesthesiologists perform central venous catheterization.
Read the detailed description
After anesthesia induction and tracheal intubation, we will prepare central venous catheterization for patients requiring it. After anesthesiologists who are blinded to this study perform central venous catheterization, an investigator measured the shortest distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle.
- Conditions
- Central Venous Catheterization
- Being tested
- central venous cathterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous cathterizationDevice
central venous catheterization through the right internal jugular vein
What is being measured
The primary outcome is the main question the study is designed to answer.
puncture site
distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start16 Aug 2021 (estimated)
- Primary completion16 Jul 2022 (estimated)
- Study completion16 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, MD.PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916288
- Sponsor's protocol ID
- 10-2020-213
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there would be a proper reason, I will share the data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position of Puncture Point of the Introducer Needle During Internal Jugular Venous Catheterization With Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT04916288
- Acronym / sponsor ID
- 10-2020-213
- Conditions
- Central Venous Catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 16 Aug 2021 (estimated)
- Primary completion
- 16 Jul 2022 (estimated)
- Study completion
- 16 Aug 2022 (estimated)
- First posted
- 7 Jun 2021 (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 this observational study, we will measure the shortest distance from the cricoid cartilage level to the puncture site of the introducer needle when anesthesiologists perform central venous catheterization.
Detailed description
After anesthesia induction and tracheal intubation, we will prepare central venous catheterization for patients requiring it. After anesthesiologists who are blinded to this study perform central venous catheterization, an investigator measured the shortest distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years old) scheduled to elective surgery requiring central venous catheterization under general anesthesia.
Key inclusion criteria (2 listed)
- elective surgery under general anesthesia
- requirement of central venous catheterization
Key exclusion criteria (1 listed)
- disagreement for participation
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 |
|---|---|---|
| central venous cathterizationcentral venous catheterization through the right internal jugular vein | Device | – |
Primary outcome
puncture site
Time frame: intraoperative
distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided. If there would be a proper reason, I will share the data to other researchers.
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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.
Jung-Man Lee, 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 Central Venous 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 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: status not confirmed, as of the sponsor's last update on 16 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Man Lee, MD.PhD (+82-2-870-2513, jungman007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
puncture site (time frame: intraoperative). 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 16 Aug 2021.