Ipsilateral NippleNCT01347463
Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization
An observational study of Ipsilateral Nipple and Internal Jugular Vein, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds. The investigators attempt to validate this long-standing statement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ipsilateral Nipple, Internal Jugular Vein, Catheterization
- What is being tested?
- SCM triangle - ipsilateral nipple
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Dec 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled to undergo general anesthesia
Who may be able to join
- adult patients over the age of 18 undergoing general anesthesia
Who cannot join
- history of neck or breast surgery
- anatomical anomaly of the neck or breast
- neck mass
- breast mass
Trial locations and contacts
1 site in 1 country.
About this study
Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.
The investigators attempt to validate this long-standing statement.
- Conditions
- Ipsilateral Nipple, Internal Jugular Vein, Catheterization
- Being tested
- SCM triangle - ipsilateral nipple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCM triangle - ipsilateral nippleProcedure or surgery
draws the tract of the IJV using the SCM triangle head and the ipsilateral nipple
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Not described Receives: Procedure: SCM triangle - ipsilateral nipple |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in angle
difference in angle between traditional (triangular head of the SCM - ipsilateral nipple) and ultrasound guided tract
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ipsilateral NippleStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347463
- Sponsor's protocol ID
- IJV-cath-nipple
- Status last verified
- Aug 2020
- First submitted
- 29 Apr 2011
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Ipsilateral Nipple as the Directional Guide for Internal Jugular Vein (IJV) Catheterization
- ClinicalTrials.gov ID
- NCT01347463
- Acronym / sponsor ID
- IJV-cath-nipple
- Conditions
- Ipsilateral Nipple, Internal Jugular Vein, Catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 May 2011 (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.
Traditional teaching that suggests the ipsilateral nipple as the directional guide for needle advancement during Internal Jugular Vein (IJV) catheterization has weak grounds.
The investigators attempt to validate this long-standing statement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traditional | – | Procedure: SCM triangle - ipsilateral nipple |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled to undergo general anesthesia
Key inclusion criteria (1 listed)
- adult patients over the age of 18 undergoing general anesthesia
Key exclusion criteria (4 listed)
- history of neck or breast surgery
- anatomical anomaly of the neck or breast
- neck mass
- breast mass
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 |
|---|---|---|
| SCM triangle - ipsilateral nippledraws the tract of the IJV using the SCM triangle head and the ipsilateral nipple | Procedure or surgery | Traditional |
Primary outcome
difference in angle
Time frame: 1 day
difference in angle between traditional (triangular head of the SCM - ipsilateral nipple) and ultrasound guided tract
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 5 Aug 2020.
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 Ipsilateral Nipple and Internal Jugular Vein, 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 1 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 5 Aug 2020. 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?
difference in angle (time frame: 1 day). 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 5 Aug 2020.