Need for Central Venous AccessNCT01680666
A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population
A study testing central line placement and Ultrasound in people with Need for Central Venous Access, run by Stanford University at 2 sites in United States.
Trial summary
The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Need for Central Venous Access
- What is being tested?
- central line placement and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia
Who cannot join
- Preoperative proof of non-patency of central veins
- coagulopathy
- access site surgeon
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Mercy Hospital
Kansas City, Missouri
Stanford University
Palo Alto, California, 94304
About this study
Official title: A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children
The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.
- Conditions
- Need for Central Venous Access
- Being tested
- central line placement, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central line placementProcedure or surgery
central line placement
UltrasoundDevice
Also called Sonosite, Bothel, WA, Aloka, Wallingford, CT
Ultrasound guided central venous access
| Study group | Role | What they receive |
|---|---|---|
| landmark guided | Active comparator | central line placement Receives: Procedure: central line placement |
| ultrasound guided | Active comparator | central line placement Receives: Procedure: central line placement; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Central Venous Cannulation at First Attempt
The count (%) of patients with successful central venous cannulation at first attempt is reported.
Measured: Up to 410 seconds
Secondary outcomes (4)
Success of Central Venous Cannulation Within First Three Attempts
The count (%) of patients with successful central venous cannulation within the first three attempts is reported.
Measured: Up to 410 seconds
Patients With Arterial Punctures
The count (%) of patients with arterial punctures is presented.
Measured: Up to 410 seconds
Patients With Complications
The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.
Measured: Up to 410 seconds
Time to Successful Cannulation
Measured: Up to 410 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startMay 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Need for Central Venous AccessStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Bruzoni, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680666
- Sponsor's protocol ID
- IRB-8943
- Status last verified
- Oct 2017
- First submitted
- 28 Aug 2012
- Last updated
- 9 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.
PubMed 23478546
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children
- ClinicalTrials.gov ID
- NCT01680666
- Acronym / sponsor ID
- IRB-8943
- Conditions
- Need for Central Venous Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| landmark guided | Active comparator | Procedure: central line placementcentral line placement |
| ultrasound guided | Active comparator | Procedure: central line placement, Device: Ultrasoundcentral line placement |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia
Key exclusion criteria (3 listed)
- Preoperative proof of non-patency of central veins
- coagulopathy
- access site surgeon
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 line placementcentral line placement | Procedure or surgery | landmark guided, ultrasound guided |
| UltrasoundAlso: Sonosite, Bothel, WA, Aloka, Wallingford, CTUltrasound guided central venous access | Device | ultrasound guided |
Primary outcome
Success of Central Venous Cannulation at First Attempt
Time frame: Up to 410 seconds
The count (%) of patients with successful central venous cannulation at first attempt is reported.
4 secondary outcomes
Success of Central Venous Cannulation Within First Three Attempts
Time frame: Up to 410 seconds
Patients With Arterial Punctures
Time frame: Up to 410 seconds
Patients With Complications
Time frame: Up to 410 seconds
Time to Successful Cannulation
Time frame: Up to 410 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23478546Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing central line placement and Ultrasound in people with Need for Central Venous Access, run by Stanford University at 2 sites in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Central Venous Cannulation at First Attempt (time frame: Up to 410 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680666, which also lists 1 linked publication.
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 9 Nov 2017.