Safety Study of Subclavian and Internal Jugular Venous Catheterization
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety Study 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 |
- Time to completely insertion [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
- rates of mechanical, infectious, and thrombotic complications [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Yu-Feng Wei, M.D. | +886-7-615-0011 ext 2980 | ed102746@edah.org.tw |
| 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. | |
| Principal Investigator: | Yu-Feng Wei, M.D. | Chest department |
More Information
No publications provided
| Responsible Party: | E-DA Hospital |
| ClinicalTrials.gov Identifier: | NCT01196962 History of Changes |
| Other Study ID Numbers: | CSIS, EDAH |
| Study First Received: | September 1, 2010 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by E-DA Hospital:
|
central venous catheter complications internal jugular vein randomized trial subclavian vein |
ClinicalTrials.gov processed this record on May 19, 2013