UltrasoundNCT05717556
Success of Internal Jugular Vein Catheterization
A study testing Internal Jugular Vein Catheterization in people with Ultrasound and Catheterization, run by Zonguldak Bulent Ecevit University at 2 sites in Turkey (Türkiye).
Trial summary
Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Catheterization, Volume Status
- What is being tested?
- Internal Jugular Vein Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2022
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-75
- underwent coronary artery bypass surgery
Who cannot join
- <18 years old
- Hemodynamic instability
- Use of inotropic agents
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Zonguldak Bülent Ecevit University Faculty of Medicine
Kozlu, Esenköy, 67600
Zongulak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: Factors Affecting Success of First Attempt in Ultrasonography-Guided Internal Jugular Vein Catheterization
Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). In addition, the initial entry success rate in the USG supported group is 65%. , this rate remained at 45% with the blind technique.
Although Pleth variability index monitoring is a noninvasive method, it is a technique that consistently predicts fluid sensitivity in patients under mechanical ventilation.
The aim of study is before applying USG guided catheterization; We think that by revealing the factors of the patient that are effective on the number of interventions, necessary measures can be taken for the success of catheterization as a result.
- Conditions
- Ultrasound, Catheterization, Volume Status
- Being tested
- Internal Jugular Vein Catheterization
- Keywords
- juguler vein catheterization, ultrasound guidance, pleth variability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Jugular Vein CatheterizationProcedure or surgery
Inserting a cannula into the internal jugular vein
| Study group | Role | What they receive |
|---|---|---|
| single attempt catheterization | Active comparator | successful catheterization with a single attempt number Receives: Procedure: Internal Jugular Vein Catheterization |
| multiple attempts catheterization | Active comparator | successful catheterization after multiple attempts Receives: Procedure: Internal Jugular Vein Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors of internal vein jugular catheterization success
neck circumference,
Measured: Baseline (Before catheterization)
factors of internal vein jugular catheterization success
internal juguler vein depth
Measured: Baseline (Before catheterization)
factors of internal vein jugular catheterization success
internal vein diameter
Measured: Baseline (Before catheterization)
factors of internal vein jugular catheterization success
pleth variability index
Measured: Baseline (Before catheterization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Köksal, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717556
- Sponsor's protocol ID
- 2018/12-6
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Success of First Attempt in Ultrasonography-Guided Internal Jugular Vein Catheterization
- ClinicalTrials.gov ID
- NCT05717556
- Acronym / sponsor ID
- 2018/12-6
- Conditions
- Ultrasound, Catheterization, Volume Status
- Keywords
- juguler vein catheterization, ultrasound guidance, pleth variability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 8 Feb 2023 (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.
Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). In addition, the initial entry success rate in the USG supported group is 65%. , this rate remained at 45% with the blind technique.
Although Pleth variability index monitoring is a noninvasive method, it is a technique that consistently predicts fluid sensitivity in patients under mechanical ventilation.
The aim of study is before applying USG guided catheterization; We think that by revealing the factors of the patient that are effective on the number of interventions, necessary measures can be taken for the success of catheterization as a result.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single attempt catheterization | Active comparator | Procedure: Internal Jugular Vein Catheterizationsuccessful catheterization with a single attempt number |
| multiple attempts catheterization | Active comparator | Procedure: Internal Jugular Vein Catheterizationsuccessful catheterization after multiple attempts |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-75
- underwent coronary artery bypass surgery
Key exclusion criteria (3 listed)
- <18 years old
- Hemodynamic instability
- Use of inotropic agents
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 |
|---|---|---|
| Internal Jugular Vein CatheterizationInserting a cannula into the internal jugular vein | Procedure or surgery | multiple attempts catheterization, single attempt catheterization |
Primary outcome
factors of internal vein jugular catheterization success
Time frame: Baseline (Before catheterization)
neck circumference,
factors of internal vein jugular catheterization success
Time frame: Baseline (Before catheterization)
internal juguler vein depth
factors of internal vein jugular catheterization success
Time frame: Baseline (Before catheterization)
internal vein diameter
factors of internal vein jugular catheterization success
Time frame: Baseline (Before catheterization)
pleth variability index
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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Jugular Vein Catheterization in people with Ultrasound and Catheterization, run by Zonguldak Bulent Ecevit University at 2 sites in Turkey (Türkiye).
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 3 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
factors of internal vein jugular catheterization success (time frame: Baseline (Before catheterization)). The study lists 4 primary outcomes in all. 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 8 Feb 2023.