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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03303274
Other study ID # 1707-110-871-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 25, 2017
Last updated October 2, 2017
Start date October 20, 2017
Est. completion date July 31, 2019

Study information

Verified date October 2017
Source Seoul National University Hospital
Contact Hyung-Chul Lee, MD
Phone +82-10-2456-6336
Email lucid80@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 second stage of this study, the investigators would like to compare the success rate, the number of needle passage, time to complete subclavian vein catheterization in supine and ipsilateral tile position.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 220
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ipsilateral tilt
The operation table will be tilted 20 degrees right laterally.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The number of needle passage The number of needle passage for puncture of subclavian vein during subclavian venous catheterization
Secondary Time to puncture subclavian vein Time to puncture subclavian vein during subclavian venous catheterization
Secondary Time to insert guidewire Time to insert guidewire during subclavian venous catheterization
Secondary Time to insert dilator Time to insert dilator during subclavian venous catheterization
Secondary The number of trial to insert catheter The number of trial to insert catheter during subclavian venous catheterization
Secondary Time to insert catheter Time to insert catheter during subclavian venous catheterization
Secondary Success of catheter insertion Final success of catheter insertion within 6 trials during subclavian venous catheterization
Secondary Other complications with central venous catheterization complications with central venous catheterization such as arterial puncture, perivascular hematoma, pneumothorax, and malpositioning From subclavian venous catheterization to 24 hours after operation finished
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