Catheterization, PeripheralNCT00557154
Ultrasound Assisted Peripheral Venous Access in Young Children
A study testing ultrasound and standard technique for venipuncture in people with Catheterization, Peripheral, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- ultrasound and standard technique for venipuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jul 2004
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Less than 7 years of age
- Emergency Department patients
- Parents available for consent
Who cannot join
- Critical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Ultrasound Assisted Peripheral Venous Access in Young Children: A Pilot and Feasibility Randomized Controlled Trial
The purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children.
Read the detailed description
In an academic pediatric Emergency Depratment (ED), we performed a randomized clinical trial of children < 7 years of age, who required i.v. access and who had failed the first i.v. attempt. We randomized patients to either continued standard i.v. attempts or ultrasound-assisted attempts. Clinicians involved in the study received one hour of training in ultrasound localization of peripheral veins. In the ultrasound group, vein localization was performed by an ED physician who marked the skin overlying the target vessel. Intravenous cannulation attempts were then immediately performed by a pediatric ED nurse who relied on the skin mark for vessel location. We allowed for technique cross-over after two failed i.v. attempts. We recorded success rate and location of access attempts.
- Conditions
- Catheterization, Peripheral
- Being tested
- ultrasound, standard technique for venipuncture
- Keywords
- Pediatrics, Venous access, Emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
ultrasound used to identify target vein
standard technique for venipunctureDevice
routine equipment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ultrasound used to visualize peripheral venous anatomy. This guides subsequent attempts at venipuncture. Receives: Device: ultrasound |
| 2 | Active comparator | Routine venipuncture using standard methods. Receives: Device: standard technique for venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
venous visualization (with ultrasound) and venipuncture success rate
Measured: one year
Secondary outcomes (1)
Anticipated difficulty of venipuncture (rated on visual analog scale)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startAug 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Investigators
- Aaron E Bair, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557154
- Sponsor's protocol ID
- 200210274
- Other IDs
- S-9400847-018LA
- Status last verified
- Nov 2007
- First submitted
- 8 Nov 2007
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assisted Peripheral Venous Access in Young Children: A Pilot and Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00557154
- Acronym / sponsor ID
- 200210274
- Conditions
- Catheterization, Peripheral
- Keywords
- Pediatrics, Venous access, Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- Aug 2003
- Study completion
- Jul 2004 (actual)
- First posted
- 12 Nov 2007 (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 purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children.
Detailed description
In an academic pediatric Emergency Depratment (ED), we performed a randomized clinical trial of children < 7 years of age, who required i.v. access and who had failed the first i.v. attempt. We randomized patients to either continued standard i.v. attempts or ultrasound-assisted attempts. Clinicians involved in the study received one hour of training in ultrasound localization of peripheral veins. In the ultrasound group, vein localization was performed by an ED physician who marked the skin overlying the target vessel. Intravenous cannulation attempts were then immediately performed by a pediatric ED nurse who relied on the skin mark for vessel location. We allowed for technique cross-over after two failed i.v. attempts. We recorded success rate and location of access attempts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ultrasoundUltrasound used to visualize peripheral venous anatomy. This guides subsequent attempts at venipuncture. |
| 2 | Active comparator | Device: standard technique for venipunctureRoutine venipuncture using standard methods. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Less than 7 years of age
- Emergency Department patients
- Parents available for consent
Key exclusion criteria (1 listed)
- Critical illness
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 |
|---|---|---|
| ultrasoundultrasound used to identify target vein | Device | 1 |
| standard technique for venipunctureroutine equipment | Device | 2 |
Primary outcome
venous visualization (with ultrasound) and venipuncture success rate
Time frame: one year
1 secondary outcome
Anticipated difficulty of venipuncture (rated on visual analog scale)
Time frame: one year
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 15 Feb 2017.
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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.
Aaron E Bair, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and standard technique for venipuncture in people with Catheterization, Peripheral, run by University of California, Davis 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 3 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 15 Feb 2017. 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?
venous visualization (with ultrasound) and venipuncture success rate (time frame: one year). 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 15 Feb 2017.