- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368692
Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization
January 14, 2013 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
362
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 82 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization
Exclusion Criteria:
- infection over the puncture site
- history of prior clavicular fracture
- anatomical anomaly of subclavian vein
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: neutral shoulder
neutral shoulder position during subclavian vein catheterization
|
neutral shoulder position during subclavian vein catheterization
|
|
Experimental: shoulder retraction
position of shoulder retraction during subclavian vein catheterization
|
position of shoulder retraction by placing a saline bag between the scapula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
catheterization success rate
Time Frame: immediately after catheterization (an expected average of 1 hour)
|
Subclavian vein catheterization will be performed after the induction of anesthesia and before the start of surgery.
|
immediately after catheterization (an expected average of 1 hour)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
location of catheter tip
Time Frame: an expected average of one day after surgery
|
Postoperative chest X-ray will be taken to check for the location of catheter tip immediately after surgery.
|
an expected average of one day after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
May 22, 2011
First Submitted That Met QC Criteria
June 6, 2011
First Posted (Estimate)
June 8, 2011
Study Record Updates
Last Update Posted (Estimate)
January 15, 2013
Last Update Submitted That Met QC Criteria
January 14, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- H-1103-124-357
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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