Patient Safety During Central Venous CatheterizationNCT03116724
Direct Measurement of Ideal Depth of Central Line
A study testing central venous catheterization through Rt. IJV in people with Patient Safety During Central Venous Catheterization, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Total of 89 patients undergoing elective cardiac surgery will be enrolled. Right CVC insertion begins at their intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety During Central Venous Catheterization
- What is being tested?
- central venous catheterization through Rt. IJV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2017to 28 Aug 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient over 18 years of age undergoing cardiac surgery under general anesthesia, requiring central venous catheter insertion through the right internal jugular vein and insertion of a TEE probe
Who cannot join
- Patients who disagree with the study.
- Patients who had difficulty in inserting the central line through the right internal jugular vein.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Measurement of Ideal Depth of Central Line for Right Internal Jugular Venous Catheterization in Adults
Total of 89 patients undergoing elective cardiac surgery will be enrolled.
Right CVC insertion begins at their intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head. After insertion the central venous catheter through the right internal jugular vein and positioning it, the location of the tip of the central venous catheter will be confirmed by TEE.
Read the detailed description
Investigator confirms the location of the 2 cm from the junction between right atrium and superior vena cava to the end of the tip of the catheter using TEE, and measures the insertion depth of the catheter at insertion point. It is possible to find the ideal central venous catheter insertion depth in actual clinical practice in adult patient.
The ideal central venous catheter insertion depth can be measured accurately when the end of the central venous catheter is monitored with transesophageal ultrasonography, and it can be derived a meaningful formula for predicting the ideal central venous insertion depth from the patient's height .
- Being tested
- central venous catheterization through Rt. IJV
- Keywords
- catheterization, central venous, jugular veins, echocardiography, transesophageal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheterization through Rt. IJVProcedure or surgery
- insertion at the intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head
- placement of the tip of the catheter 2 cm away from the junction between right atrium and superior vena cava using TEE
- measurement of the depth of the catheter at insertion point
| Study group | Role | What they receive |
|---|---|---|
| CVC catheterization through Rt. IJV | Experimental | The depth of central venous catheter during central venous catheterization through Rt. IJV will be decided by using real-time TEE.
The position of tip of CVC will be guided by TEE to fit the tip at 2 cm away from the junction between right atrium and superior vena cava. Receives: Procedure: central venous catheterization through Rt. IJV |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of the central venous catheter in right internal jugular vein
Measured: at time of insertion of the central venous catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start5 Apr 2017
- Primary completion25 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Safety During Central Venous CatheterizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwon Lee, Keimyung University Dongsan Medical Center
- Investigators
- Jiwon Lee, Dr., Principal investigator, Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116724
- Sponsor's protocol ID
- ideal depth of central line
- Status last verified
- Jun 2020
- First submitted
- 4 Apr 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Measurement of Ideal Depth of Central Line for Right Internal Jugular Venous Catheterization in Adults
- ClinicalTrials.gov ID
- NCT03116724
- Acronym / sponsor ID
- ideal depth of central line
- Keywords
- catheterization, central venous, jugular veins, echocardiography, transesophageal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 17 Apr 2017 (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.
Total of 89 patients undergoing elective cardiac surgery will be enrolled.
Right CVC insertion begins at their intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head. After insertion the central venous catheter through the right internal jugular vein and positioning it, the location of the tip of the central venous catheter will be confirmed by TEE.
Detailed description
Investigator confirms the location of the 2 cm from the junction between right atrium and superior vena cava to the end of the tip of the catheter using TEE, and measures the insertion depth of the catheter at insertion point. It is possible to find the ideal central venous catheter insertion depth in actual clinical practice in adult patient.
The ideal central venous catheter insertion depth can be measured accurately when the end of the central venous catheter is monitored with transesophageal ultrasonography, and it can be derived a meaningful formula for predicting the ideal central venous insertion depth from the patient's height .
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVC catheterization through Rt. IJV | Experimental | Procedure: central venous catheterization through Rt. IJVThe depth of central venous catheter during central venous catheterization through Rt. IJV will be decided by using real-time TEE. The position of tip of CVC will be guided by TEE to fit the tip at 2 cm away from the junction between right atrium and superior vena cava. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient over 18 years of age undergoing cardiac surgery under general anesthesia, requiring central venous catheter insertion through the right internal jugular vein and insertion of a TEE probe
Key exclusion criteria (2 listed)
- Patients who disagree with the study.
- Patients who had difficulty in inserting the central line through the right internal jugular vein.
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 catheterization through Rt. IJV* insertion at the intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head * placement of the tip of the catheter 2 cm away from the junction between right atrium and superior vena cava using TEE * measurement of the depth of the catheter at insertion point | Procedure or surgery | CVC catheterization through Rt. IJV |
Primary outcome
depth of the central venous catheter in right internal jugular vein
Time frame: at time of insertion of the central venous catheter
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 16 Jun 2020.
- Individual participant dataSharing planned: No
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.
Jiwon Lee, Dr. principal investigator
Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing central venous catheterization through Rt. IJV in people with Patient Safety During Central Venous Catheterization, run by Keimyung University Dongsan 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 2 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 16 Jun 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?
depth of the central venous catheter in right internal jugular vein (time frame: at time of insertion of the central venous catheter). 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 Jun 2020.