IV CannulationNCT00935909
Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access
An observational study of IV Cannulation, run by Peter Szmuk at 1 site in United States.
Trial summary
The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- IV Cannulation
- How many people
- 603 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2010
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The floor patients meeting the inclusion/exclusion criteria that need an IV
Who may be able to join
- Patients age 0-18 requiring IV cannula (ASA 1-4) with a modified DIVA score ≥ 2 at the time of assessment
Who cannot join
- Patients with visible veins will be excluded from the study as well as patients with known difficult IV access which are scheduled for PICC line placement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center Dallas
Dallas, Texas, 75235
About this study
Official title: Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access.
The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation.
Read the detailed description
A single initial data page will be filled out by one of the study team members present with the IV Team at the time of the cannulation. The data from these forms will be entered by the investigator or research assistant into a database maintained only for this study. There will be two groups in this randomized study. One group will receive IV cannulation with the VV and the second group will receive standard cannulation without the VV. The chance of receiving either treatment is based on randomly generated computer codes, unknown by the IV team. We want to evaluate successful IV cannulation on first attempt as well as the time taken for cannulation. All documents will be de-identified of data that contains HIPAA protected health information (PHI) at the end of the study. We estimate approximate enrollment to be 790 children. The study is expected to last 12 months and will only be conducted at Children's Medical Center Dallas.
- Conditions
- IV Cannulation
- Keywords
- IV cannulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful IV cannulation on the first attempt
Measured: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.
Secondary outcomes (1)
Total time to successful IV cannulation
Measured: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IV CannulationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Szmuk
- Sponsor type
- University, hospital or other
- Collaborators
- Luminex Corporation, Outcomes Research Consortium
- Responsible party
- Sponsor-investigator, Peter Szmuk, University of Texas Southwestern Medical Center
- Investigators
- Peter Szmuk, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935909
- Sponsor's protocol ID
- 112008-014
- Status last verified
- Jun 2013
- First submitted
- 2 Jul 2009
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access.
- ClinicalTrials.gov ID
- NCT00935909
- Acronym / sponsor ID
- 112008-014
- Conditions
- IV Cannulation
- Keywords
- IV cannulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Peter SzmukUniversity, hospital or other
- Collaborators
- Luminex Corporation, Outcomes Research Consortium
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Jul 2009 (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.
The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation.
Detailed description
A single initial data page will be filled out by one of the study team members present with the IV Team at the time of the cannulation. The data from these forms will be entered by the investigator or research assistant into a database maintained only for this study. There will be two groups in this randomized study. One group will receive IV cannulation with the VV and the second group will receive standard cannulation without the VV. The chance of receiving either treatment is based on randomly generated computer codes, unknown by the IV team. We want to evaluate successful IV cannulation on first attempt as well as the time taken for cannulation. All documents will be de-identified of data that contains HIPAA protected health information (PHI) at the end of the study. We estimate approximate enrollment to be 790 children. The study is expected to last 12 months and will only be conducted at Children's Medical Center Dallas.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The floor patients meeting the inclusion/exclusion criteria that need an IV
Key inclusion criteria (1 listed)
- Patients age 0-18 requiring IV cannula (ASA 1-4) with a modified DIVA score ≥ 2 at the time of assessment
Key exclusion criteria (1 listed)
- Patients with visible veins will be excluded from the study as well as patients with known difficult IV access which are scheduled for PICC line placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful IV cannulation on the first attempt
Time frame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.
1 secondary outcome
Total time to successful IV cannulation
Time frame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
Related trials for IV Cannulation
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
Peripheral Intravenous Cannulation, Pain Management
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.
Peter Szmuk, MD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IV Cannulation, run by Peter Szmuk at 1 site 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 1 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 21 Jun 2013. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful IV cannulation on the first attempt (time frame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.). 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 21 Jun 2013.