Clinical trial NCT03303274: A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage II
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheterization
Posture
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-10-06
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility 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)

Primary outcomes:
measure: The number of needle passage
timeFrame: during subclavian venous catheterization
Secondary outcomes:
measure: Time to puncture subclavian vein
timeFrame: during subclavian venous catheterization
measure: Time to insert guidewire
timeFrame: during subclavian venous catheterization
measure: Time to insert dilator
timeFrame: during subclavian venous catheterization
measure: The number of trial to insert catheter
timeFrame: during subclavian venous catheterization
measure: Time to insert catheter
timeFrame: during subclavian venous catheterization
measure: Success of catheter insertion
timeFrame: during subclavian venous catheterization
measure: Other complications with central venous catheterization
timeFrame: From subclavian venous catheterization to 24 hours after operation finished
Other outcomes:
Locations:
Study officials:
References:
citation: Yoon HK, Lee HC, Kang P, Lee JM, Park HP, Cho YJ. Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial. BMC Anesthesiol. 2020 Sep 5;20(1):226. doi: 10.1186/s12871-020-01144-1.
citation: Jung DE, Lee HC, Yoon HK, Park HP. The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial. Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.