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A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I

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ClinicalTrials.gov Identifier: NCT03296735
Recruitment Status : Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Brief Summary:

Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.

In the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.


Condition or disease Intervention/treatment Phase
Catheterization Posture Procedure: Ipsilateral tilt Procedure: Contralateral tilt Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: Ipsilateral tilt
Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.
Procedure: Ipsilateral tilt
The operation table will be tilted 20 degrees right laterally.

No Intervention: Supine
Measuring the cross-sectional area of right subclavian vein in supine position.
Active Comparator: Contralateral tilt
Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.
Procedure: Contralateral tilt
The operation table will be tilted 20 degrees left laterally.




Primary Outcome Measures :
  1. The cross-sectional area of right subclavian vein [ Time Frame: 1 minutes after position change ]
    The cross-sectional area of right subclavian vein



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- the patients who receive elective neurosurgical surgery and require central venous catheter

Exclusion Criteria:

  • the patients who have puncture site infection
  • the patients who have chemoport, pacemaker in right subclavian vein
  • the patients who had received right mastectomy or right pneumonectomy
  • other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)

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): NCT03296735


Contacts
Contact: Hyung-Chul Lee, MD +82-10-2456-6336 lucid80@gmail.com

Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hee-Pyoung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03296735     History of Changes
Other Study ID Numbers: 2017-110-871-1
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

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