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Safety Study of Subclavian and Internal Jugular Venous Catheterization
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by E-DA Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
E-DA Hospital
Information provided by (Responsible Party):
E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01196962
First received: September 1, 2010
Last updated: November 22, 2012
Last verified: August 2011
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Purpose
There is no randomized controlled trial to compare the rates of complications associated with internal jugular and subclavian venous catheterization. The aim of this study is to compare mechanical, infectious, and thrombotic complications of internal jugular and subclavian venous catheterization. An improved understanding of CVC-related risks might help clinicians to choose one approach over the other in specific clinical settings.
| Condition | Intervention |
|---|---|
| Time to Insertion Rates of Complications | Device: Central venous catheter |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients |
Further study details as provided by E-DA Hospital:
Primary Outcome Measures:
- Time to completely insertion [ Time Frame: 1 hour ]
Secondary Outcome Measures:
- rates of mechanical, infectious, and thrombotic complications [ Time Frame: 14 days ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Internal jugular vein |
Device: Central venous catheter
Central venous catheter insertion to subclavian vein
Other Name: venous access
|
Detailed Description:
Central venous catheterization is often necessary to treat critically ill patients hospitalized in intensive care units (ICUs). However, this procedure may lead to serious and sometimes life-threatening complications, including mechanical, infectious, or thrombotic complications. The choice of insertion site can influence the incidence and type of such complications. The most frequently used sites for CVC insertion are the internal jugular and the subclavian vein. However, in an individual patient, criteria for choosing one approach over the other remain unclear.
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- admission to ICU
- requiring central venous catheterization
- without contraindications to attempt both jugular and internal jugular access
Exclusion Criteria:
- the presence of a central venous catheter at admission
- central venous catheterization within 2 weeks prior to admission
- emergency catheterization for a life-threatening situation
- major blood coagulation disorders
- anatomic defect precluding catheterization at either site
- skin lesions or recent surgery at either site
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196962
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196962
Contacts
| Contact: Yu-Feng Wei, M.D. | +886-7-615-0011 ext 2980 | ed102746@edah.org.tw |
Locations
| Taiwan | |
| E-Da hospital | Recruiting |
| Kaohsiung, Taiwan, 7 | |
| Contact: Yu-Feng Wei, M.D. +886-7-615-0011 ext 2980 ed102746@edah.org.tw | |
| Principal Investigator: Yu-Feng Wei, M.D. | |
Sponsors and Collaborators
E-DA Hospital
Investigators
| Principal Investigator: | Yu-Feng Wei, M.D. | Chest department |
More Information
| Responsible Party: | E-DA Hospital |
| ClinicalTrials.gov Identifier: | NCT01196962 History of Changes |
| Other Study ID Numbers: |
CSIS EDAH ( Other Identifier: EDAH ) |
| Study First Received: | September 1, 2010 |
| Last Updated: | November 22, 2012 |
Keywords provided by E-DA Hospital:
|
central venous catheter complications internal jugular vein randomized trial subclavian vein |
ClinicalTrials.gov processed this record on June 26, 2017