Central Venous CatheterizationNCT03741946
Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio
A study testing Triangle of Sedillot identification using ultrasonography in people with Central Venous Catheterization and Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to find out the effect of contra lateral head rotation to distance and overlapping of internal jugular vein and carotid artery at cricoid cartilage level by ultrasound guidance on the Malay race in Indonesia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Central Venous Catheterization, Surgery
- What is being tested?
- Triangle of Sedillot identification using ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2018to 28 Feb 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA score 1 and 2
- 18-60 years old
- no anatomical abnormality in neck
Who cannot join
- obese
- has history of previous central venous catheter cannulation
- limitation on contralateral head movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio
This study aims to find out the effect of contra lateral head rotation to distance and overlapping of internal jugular vein and carotid artery at cricoid cartilage level by ultrasound guidance on the Malay race in Indonesia
Read the detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. 34 subjects were enrolled by using consecutive sampling method. Sample size was calculated by using numeric analytic comparative paired formula with repeated measurement. Inclusion criteria were patients with ASA score 1 and 2, aged between 18-60 years old, no anatomical abnormality in neck. Exclusion criteria were patients who were either obese, has history of previous central venous catheter cannulation, and limitation on contralateral head movement. Drop out criteria was abnormalities of anatomical IJV and CA. Basic demographic data, such as sex, age, body weight and height, body mass index were recorded. Patients were positioned in Trendelenburg (15°) position. Identification triangle of Sedillot at cricoid level in right neck with palpation at angle 0°. USG probe was placed upright at the top of triangle of Sedillot at cricoid level. Identification of IJV and CA was shown in transversal view then the IJV to CA distance and overlap ratio was calculated. Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle.
- Conditions
- Central Venous Catheterization, Surgery
- Being tested
- Triangle of Sedillot identification using ultrasonography
- Keywords
- carotid arteries, central venous catheterization, jugular veins, Malay race, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triangle of Sedillot identification using ultrasonographyProcedure or surgery
Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle.
| Study group | Role | What they receive |
|---|---|---|
| Triangle of Sedillot identification using ultrasonography | Other | USG probe placed upright at the top of triangle of Sedillot at cricoid level Receives: Procedure: Triangle of Sedillot identification using ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
IJV to CA distance at different contralateral rotation angle
IJV to CA distance at different contralateral rotation angle (0°, 30°, 45°, 60°)
Measured: 2 months
IJV to CA overlap ratio at different contralateral rotation angle
IJV to CA overlap ratio at different contralateral rotation angle (0°, 30°, 45°, 60°)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldy Heriwardito, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741946
- Sponsor's protocol ID
- IndonesiaUAnes025
- Status last verified
- Dec 2019
- First submitted
- 7 Nov 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lieberman JA, Williams KA, Rosenberg AL. Optimal head rotation for internal jugular vein cannulation when relying on external landmarks. Anesth Analg. 2004 Oct;99(4):982-988. doi: 10.1213/01.ANE.0000132908.77111.CA.
PubMed 15385337Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography. Guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2011 Dec;24(12):1291-318. doi: 10.1016/j.echo.2011.09.021. No abstract available.
PubMed 22115322Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD011447. doi: 10.1002/14651858.CD011447.
PubMed 25575245Sibai AN, Loutfi E, Itani M, Baraka A. Ultrasound evaluation of the anatomical characteristics of the internal jugular vein and carotid artery--facilitation of internal jugular vein cannulation. Middle East J Anaesthesiol. 2008 Oct;19(6):1305-20.
PubMed 18942245Saitoh T, Satoh H, Kumazawa A, Nobuhara M, Machii M, Tanaka T, Shiraki K, Saotome M, Urushida T, Katoh H, Hayashi H. Ultrasound analysis of the relationship between right internal jugular vein and common carotid artery in the left head-rotation and head-flexion position. Heart Vessels. 2013 Sep;28(5):620-5. doi: 10.1007/s00380-012-0283-0. Epub 2012 Sep 12.
PubMed 22968853Troianos CA, Kuwik RJ, Pasqual JR, Lim AJ, Odasso DP. Internal jugular vein and carotid artery anatomic relation as determined by ultrasonography. Anesthesiology. 1996 Jul;85(1):43-8. doi: 10.1097/00000542-199607000-00007.
PubMed 8694381Miki I, Murata S, Nakazawa K, Onozawa S, Mine T, Ueda T, Yamaguchi H, Yasui D, Takeda M, Kumita S. Anatomical relationship between the common carotid artery and the internal jugular vein during head rotation. Ultrasound. 2014 May;22(2):99-103. doi: 10.1177/1742271X14524571. Epub 2014 Feb 25.
PubMed 27433202DeAngelis V, Denny J, Chyu D, Jan T, Lemaire A, Chiricolo A, Solina A. The Optimal Angle of Head Rotation for Internal Jugular Cannulation as Determined by Ultrasound Evaluation. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1257-60. doi: 10.1053/j.jvca.2015.02.007. Epub 2015 Feb 9.
PubMed 25998069Shoja MM, Ardalan MR, Tubbs RS, Loukas M, Vahedinia S, Jabbary R, Jalilvand M, Shakeri A. The relationship between the internal jugular vein and common carotid artery in the carotid sheath: the effects of age, gender and side. Ann Anat. 2008;190(4):339-43. doi: 10.1016/j.aanat.2008.04.002. Epub 2008 May 27.
PubMed 18595678
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio
- ClinicalTrials.gov ID
- NCT03741946
- Acronym / sponsor ID
- IndonesiaUAnes025
- Conditions
- Central Venous Catheterization, Surgery
- Keywords
- carotid arteries, central venous catheterization, jugular veins, Malay race, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 15 Nov 2018 (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.
This study aims to find out the effect of contra lateral head rotation to distance and overlapping of internal jugular vein and carotid artery at cricoid cartilage level by ultrasound guidance on the Malay race in Indonesia
Detailed description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. 34 subjects were enrolled by using consecutive sampling method. Sample size was calculated by using numeric analytic comparative paired formula with repeated measurement. Inclusion criteria were patients with ASA score 1 and 2, aged between 18-60 years old, no anatomical abnormality in neck. Exclusion criteria were patients who were either obese, has history of previous central venous catheter cannulation, and limitation on contralateral head movement. Drop out criteria was abnormalities of anatomical IJV and CA. Basic demographic data, such as sex, age, body weight and height, body mass index were recorded. Patients were positioned in Trendelenburg (15°) position. Identification triangle of Sedillot at cricoid level in right neck with palpation at angle 0°. USG probe was placed upright at the top of triangle of Sedillot at cricoid level. Identification of IJV and CA was shown in transversal view then the IJV to CA distance and overlap ratio was calculated. Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triangle of Sedillot identification using ultrasonography | Other | Procedure: Triangle of Sedillot identification using ultrasonographyUSG probe placed upright at the top of triangle of Sedillot at cricoid level |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA score 1 and 2
- 18-60 years old
- no anatomical abnormality in neck
Key exclusion criteria (3 listed)
- obese
- has history of previous central venous catheter cannulation
- limitation on contralateral head movement
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 |
|---|---|---|
| Triangle of Sedillot identification using ultrasonographyContralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle. | Procedure or surgery | Triangle of Sedillot identification using ultrasonography |
Primary outcome
IJV to CA distance at different contralateral rotation angle
Time frame: 2 months
IJV to CA distance at different contralateral rotation angle (0°, 30°, 45°, 60°)
IJV to CA overlap ratio at different contralateral rotation angle
Time frame: 2 months
IJV to CA overlap ratio at different contralateral rotation angle (0°, 30°, 45°, 60°)
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 2 Jan 2020.
- Background: PubMed 15385337Lieberman JA, Williams KA, Rosenberg AL. Optimal head rotation for internal jugular vein cannulation when relying on external landmarks. Anesth Analg. 2004 Oct;99(4):982-988. doi: 10.1213/01.ANE.0000132908.77111.CA.
- Background: PubMed 22115322Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography. Guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2011 Dec;24(12):1291-318. doi: 10.1016/j.echo.2011.09.021. No abstract available.
- Background: PubMed 25575245Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD011447. doi: 10.1002/14651858.CD011447.
- Background: PubMed 18942245Sibai AN, Loutfi E, Itani M, Baraka A. Ultrasound evaluation of the anatomical characteristics of the internal jugular vein and carotid artery--facilitation of internal jugular vein cannulation. Middle East J Anaesthesiol. 2008 Oct;19(6):1305-20.
- Background: PubMed 22968853Saitoh T, Satoh H, Kumazawa A, Nobuhara M, Machii M, Tanaka T, Shiraki K, Saotome M, Urushida T, Katoh H, Hayashi H. Ultrasound analysis of the relationship between right internal jugular vein and common carotid artery in the left head-rotation and head-flexion position. Heart Vessels. 2013 Sep;28(5):620-5. doi: 10.1007/s00380-012-0283-0. Epub 2012 Sep 12.
- Background: PubMed 8694381Troianos CA, Kuwik RJ, Pasqual JR, Lim AJ, Odasso DP. Internal jugular vein and carotid artery anatomic relation as determined by ultrasonography. Anesthesiology. 1996 Jul;85(1):43-8. doi: 10.1097/00000542-199607000-00007.
- Background: PubMed 27433202Miki I, Murata S, Nakazawa K, Onozawa S, Mine T, Ueda T, Yamaguchi H, Yasui D, Takeda M, Kumita S. Anatomical relationship between the common carotid artery and the internal jugular vein during head rotation. Ultrasound. 2014 May;22(2):99-103. doi: 10.1177/1742271X14524571. Epub 2014 Feb 25.
- Background: PubMed 25998069DeAngelis V, Denny J, Chyu D, Jan T, Lemaire A, Chiricolo A, Solina A. The Optimal Angle of Head Rotation for Internal Jugular Cannulation as Determined by Ultrasound Evaluation. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1257-60. doi: 10.1053/j.jvca.2015.02.007. Epub 2015 Feb 9.
- Background: PubMed 18595678Shoja MM, Ardalan MR, Tubbs RS, Loukas M, Vahedinia S, Jabbary R, Jalilvand M, Shakeri A. The relationship between the internal jugular vein and common carotid artery in the carotid sheath: the effects of age, gender and side. Ann Anat. 2008;190(4):339-43. doi: 10.1016/j.aanat.2008.04.002. Epub 2008 May 27.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triangle of Sedillot identification using ultrasonography in people with Central Venous Catheterization and Surgery, run by Universitas Indonesia at 1 site in Indonesia.
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 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 2 Jan 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 Indonesia. 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?
IJV to CA distance at different contralateral rotation angle (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03741946, which also lists 9 linked publications.
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 2 Jan 2020.