Patient Safety During Central Venous CatheterizationNCT02711761
Ideal Depth of Guide Wire for Central Catheterization
A study testing central venous catheterization in people with Patient Safety During Central Venous Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
prospective randomized double-blind controlled study 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to May 2016
- 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
- patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.
- ASA (American Society of Anesthesiologist) physical status class I or II
Who cannot join
- at the pre-anesthetic evaluation, history of any arrhythmia
- when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.
- abnormal electrolyte at the pre-anesthetic evaluation
- too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion
prospective randomized double-blind controlled study
Read the detailed description
Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.
Randomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)
Central catheterization will be performed by anesthesiologists who be blinded to this study protocol.
An investigator will monitor and record whether any arrhythmia will occur.
The incidence of occurrence of arrhythmia will be compared between three groups.
- Being tested
- central venous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheterizationDevice
15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm.
17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm.
20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm.
| Study group | Role | What they receive |
|---|---|---|
| 15 cm | Experimental | The depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization Receives: Device: central venous catheterization |
| 17.5 cm | Experimental | The depth of guide wire will be 17.5 cm from puncture site of skin prior to tissue dilation during central venous catheterization Receives: Device: central venous catheterization |
| 20 cm | Active comparator | The depth of guide wire will be 20 cm from puncture site of skin prior to tissue dilation during central venous catheterization Receives: Device: central venous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arrhythmia
Measured: during central venous catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMay 2016
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Boramae Hospital
- Investigators
- Jung-Man Lee, M.D., Study director, Seoul National University Boramae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711761
- Sponsor's protocol ID
- 16-2015-105
- Status last verified
- Jul 2016
- First submitted
- 14 Mar 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Depth of Guide Wire for Right Internal Jugular Vein During Central Line Insertion
- ClinicalTrials.gov ID
- NCT02711761
- Acronym / sponsor ID
- 16-2015-105
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Mar 2016 (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.
prospective randomized double-blind controlled study
Detailed description
Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.
Randomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)
Central catheterization will be performed by anesthesiologists who be blinded to this study protocol.
An investigator will monitor and record whether any arrhythmia will occur.
The incidence of occurrence of arrhythmia will be compared between three groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 cm | Experimental | Device: central venous catheterizationThe depth of guide wire will be 15 cm from puncture site of skin prior to tissue dilation during central venous catheterization |
| 17.5 cm | Experimental | Device: central venous catheterizationThe depth of guide wire will be 17.5 cm from puncture site of skin prior to tissue dilation during central venous catheterization |
| 20 cm | Active comparator | Device: central venous catheterizationThe depth of guide wire will be 20 cm from puncture site of skin prior to tissue dilation during central venous catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.
- ASA (American Society of Anesthesiologist) physical status class I or II
Key exclusion criteria (4 listed)
- at the pre-anesthetic evaluation, history of any arrhythmia
- when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.
- abnormal electrolyte at the pre-anesthetic evaluation
- too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)
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 catheterization15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm. 17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm. 20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm. | Device | 15 cm, 17.5 cm, 20 cm |
Primary outcome
Incidence of arrhythmia
Time frame: during central venous catheterization
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 11 Jul 2016.
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, M.D. study director
Seoul National University Boramae Hospital
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 in people with Patient Safety During 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 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 11 Jul 2016. 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?
Incidence of arrhythmia (time frame: during central venous catheterization). 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 11 Jul 2016.