Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017NCT03252197
A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
A study testing UGIJVC with needle guide device and UGIJVC without needle guide device in people with Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017 and Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study, run by Yonsei University at 1 site in South Korea.
Trial summary
Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation. New attachable device recently was developed for accurate needle insertion when ultrasound is used. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017, Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study
- What is being tested?
- UGIJVC with needle guide device and UGIJVC without needle guide device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2017to 24 Jun 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over 20
- Resident in clinical hospital
- Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10
Who cannot join
- If they have physical problem that is difficult to perform
- If they do not want to participate in this study
- If they can not understand the contents reading the informed consent
- If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
Seoul, 03722
About this study
Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation. New attachable device recently was developed for accurate needle insertion when ultrasound is used. Our randomized parallel simulation study will examine whether this device will improve the first attempt success rate when ultrasound guided internal jugular vein catheterization of simulated internal jugular vein.
Read the detailed description
This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.
After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.
- Conditions
- Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017, Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study
- Being tested
- UGIJVC with needle guide device, UGIJVC without needle guide device
- Keywords
- Ultrasound guided central venous cannulation, new device, first attempt success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UGIJVC with needle guide deviceDevice
Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
UGIJVC without needle guide deviceDevice
Also called Conventional group
participants who are tested performance for ultrasound guided cannulation using conventional method.
| Study group | Role | What they receive |
|---|---|---|
| New device group | Experimental | participants who are tested performance for ultrasound guided cannulation using device Receives: Device: UGIJVC with needle guide device |
| Conventional group | Active comparator | participants who are tested performance for ultrasound guided cannulation using conventional method Receives: Device: UGIJVC without needle guide device |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success
The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
Measured: Within 2 minutes or after start to insertion attempt
Secondary outcomes (4)
Posterior wall puncture of the internal jugular procedure, comfort level with procedure
It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
Measured: Within 2 minutes or after start to insertion attempt
Carotid artery puncture
It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt.
measurement unit : Yes or no (categorical variable)
Measured: Within 2 minutes or after start to insertion attempt
Time to cannulation
It was defined as the time from time out for procedure start to end point measurement unit : second
Measured: Within 2 minutes or after start to insertion attempt
Comfort level
It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.
Measured: Within 2 minutes or after start to insertion attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start11 Mar 2017
- Primary completion24 Jun 2017
- Study completion24 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252197
- Sponsor's protocol ID
- 1-2016-0081
- Status last verified
- Aug 2017
- First submitted
- 28 Jul 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
- ClinicalTrials.gov ID
- NCT03252197
- Acronym / sponsor ID
- 1-2016-0081
- Conditions
- Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017, Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study
- Keywords
- Ultrasound guided central venous cannulation, new device, first attempt success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- 24 Jun 2017 (actual)
- Study completion
- 24 Jun 2017 (actual)
- First posted
- 17 Aug 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.
Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation. New attachable device recently was developed for accurate needle insertion when ultrasound is used. Our randomized parallel simulation study will examine whether this device will improve the first attempt success rate when ultrasound guided internal jugular vein catheterization of simulated internal jugular vein.
Detailed description
This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.
After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New device group | Experimental | Device: UGIJVC with needle guide deviceparticipants who are tested performance for ultrasound guided cannulation using device |
| Conventional group | Active comparator | Device: UGIJVC without needle guide deviceparticipants who are tested performance for ultrasound guided cannulation using conventional method |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 20
- Resident in clinical hospital
- Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10
Key exclusion criteria (4 listed)
- If they have physical problem that is difficult to perform
- If they do not want to participate in this study
- If they can not understand the contents reading the informed consent
- If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor
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 |
|---|---|---|
| UGIJVC with needle guide deviceStudy subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device. | Device | New device group |
| UGIJVC without needle guide deviceAlso: Conventional groupparticipants who are tested performance for ultrasound guided cannulation using conventional method. | Device | Conventional group |
Primary outcome
First attempt success
Time frame: Within 2 minutes or after start to insertion attempt
The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
4 secondary outcomes
Posterior wall puncture of the internal jugular procedure, comfort level with procedure
Time frame: Within 2 minutes or after start to insertion attempt
Carotid artery puncture
Time frame: Within 2 minutes or after start to insertion attempt
Time to cannulation
Time frame: Within 2 minutes or after start to insertion attempt
Comfort level
Time frame: Within 2 minutes or after start to insertion attempt
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 17 Aug 2017.
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?
A study testing UGIJVC with needle guide device and UGIJVC without needle guide device in people with Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017 and Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study, run by Yonsei University 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 3 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 17 Aug 2017. 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?
First attempt success (time frame: Within 2 minutes or after start to insertion attempt). 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 17 Aug 2017.