Time to InsertionNCT01196962
Safety Study of Subclavian and Internal Jugular Venous Catheterization
A study testing Central venous catheter in people with Time to Insertion and Rates of Complications, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Time to Insertion, Rates of Complications
- What is being tested?
- Central venous catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to ICU
- requiring central venous catheterization
- without contraindications to attempt both jugular and internal jugular access
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
E-Da hospital
Kaohsiung City, 7
Yu-Feng Wei, M.D., +886-7-615-0011 ext. 2980, ed102746@edah.org.tw
Yu-Feng Wei, M.D.
About this study
Official title: A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients
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.
Read the 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.
- Conditions
- Time to Insertion, Rates of Complications
- Being tested
- Central venous catheter
- Keywords
- central venous catheter, complications, internal jugular vein, randomized trial, subclavian vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheterDevice
Also called venous access
Central venous catheter insertion to subclavian vein
| Study group | Role | What they receive |
|---|---|---|
| Internal jugular vein | Experimental | Not described Receives: Device: Central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completely insertion
Measured: 1 hour
Secondary outcomes (1)
rates of mechanical, infectious, and thrombotic complications
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time to InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Feng Wei, M.D., Principal investigator, Chest department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196962
- Sponsor's protocol ID
- CSIS
- Other IDs
- EDAH
- Status last verified
- Aug 2011
- First submitted
- 1 Sep 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01196962
- Acronym / sponsor ID
- CSIS
- Conditions
- Time to Insertion, Rates of Complications
- Keywords
- central venous catheter, complications, internal jugular vein, randomized trial, subclavian vein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internal jugular vein | Experimental | Device: Central venous catheter |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admission to ICU
- requiring central venous catheterization
- without contraindications to attempt both jugular and internal jugular access
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central venous catheterAlso: venous accessCentral venous catheter insertion to subclavian vein | Device | Internal jugular vein |
Primary outcome
Time to completely insertion
Time frame: 1 hour
1 secondary outcome
rates of mechanical, infectious, and thrombotic complications
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Feng Wei, M.D. principal investigator
Chest department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central venous catheter in people with Time to Insertion and Rates of Complications, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Feng Wei, M.D. (+886-7-615-0011 ext. 2980, ed102746@edah.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to completely insertion (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.