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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03741946
Other study ID # IndonesiaUAnes025
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date February 28, 2019

Study information

Verified date December 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 28, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- ASA score 1 and 2

- 18-60 years old

- no anatomical abnormality in neck

Exclusion Criteria:

- obese

- has history of previous central venous catheter cannulation

- limitation on contralateral head movement

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Triangle of Sedillot identification using ultrasonography
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.

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Central National Hospital Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

Brass 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:CD011447. doi: 10.1002/14651858.CD011447. Review. — View Citation

DeAngelis 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. — View Citation

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):982-8, table of contents. — View Citation

Miki 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. — View Citation

Saitoh 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. — View Citation

Shoja 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. — View Citation

Sibai 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. — View Citation

Troianos 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. — View Citation

Troianos 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary IJV to CA distance at different contralateral rotation angle IJV to CA distance at different contralateral rotation angle (0°, 30°, 45°, 60°) 2 months
Primary IJV to CA overlap ratio at different contralateral rotation angle IJV to CA overlap ratio at different contralateral rotation angle (0°, 30°, 45°, 60°) 2 months
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