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Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio

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ClinicalTrials.gov Identifier: NCT03741946
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aldy Heriwardito, Indonesia University

Brief 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

Condition or disease Intervention/treatment Phase
Central Venous Catheterization Surgery Procedure: Triangle of Sedillot identification using ultrasonography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Contralateral Head Rotation on Internal Jugular Vein to Carotid Artery Distance and Overlap Ratio
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : January 30, 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Triangle of Sedillot identification using ultrasonography
USG probe placed upright at the top of triangle of Sedillot at cricoid level
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.




Primary Outcome Measures :
  1. 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°)

  2. 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°)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741946


Contacts
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Contact: Aldy Heriwardito, MD +6281386211017 aldy.heriwardito@gmail.com

Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital Recruiting
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Publications:

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Responsible Party: Aldy Heriwardito, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03741946     History of Changes
Other Study ID Numbers: IndonesiaUAnes025
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aldy Heriwardito, Indonesia University:
carotid arteries
central venous catheterization
jugular veins
Malay race
ultrasonography