CatheterizationPhase 4VISIONNCT01133652
Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
A Phase 4 study testing Veinviewer, Ultrasound and Conventional technique in people with Catheterization and Peripheral Phlebotomy, run by University of Alberta at 1 site in Canada.
Trial summary
Children fear having an intravenous (IV) needle placed because of the pain that they will experience. The more needle punctures that a child has to endure before the IV is successfully placed, the greater the pain experienced and anxiety suffered. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Catheterization, Peripheral Phlebotomy
- What is being tested?
- Veinviewer, Ultrasound and Conventional technique
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Aug 2012
- Phase
- Phase 4
- 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 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 0-16 presenting to the Pediatric Emergency Department (PED)
- Require IV as part of routine care
- Knowledge of English language
Who cannot join
- Child in critical condition
- Child requires urgent IV placement
- Central line available
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stollery Children's Hospital Pediatric Emergency Department
Edmonton, Alberta, T6G 2 J3
About this study
Official title: The VISION STUDY: Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
Children fear having an intravenous (IV) needle placed because of the pain that they will experience. The more needle punctures that a child has to endure before the IV is successfully placed, the greater the pain experienced and anxiety suffered. In addition, false starts increase the demands on medical staff and can increase the length of the emergency department stay. Often, veins are difficult to see or feel, particularly in an unwell, dehydrated child or in young infants who have more fat below the skin surface. Also, the venous pattern below the skin surface naturally varies from person to person and therefore success in placing IVs leaves room for improvement. Technology may be able to play an important role is improving the rates of success. The investigators wish to investigate whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to the current standard approach.
Read the detailed description
Peripheral IV line placement is one of the most common and challenging painful procedures performed in the pediatric emergency department (PED). The lack of a clear visual guide for IV placement often leads to multiple painful attempts; delays in urgent treatment; increased use of human resources; increased costs; and increased anxiety in the patient, the parents and the staff. The research plan is a randomized controlled trial (RCT) to compare the use of two new technologies with the current standard method for vein location and IV placement in children.We would like to know if either of these technologies improve rates of successful IV placement on first attempt. Furthermore we would like to know if either technology leads to decreased time spent by staff on the procedure or decreased overall number of painful attempts. Information on nursing satisfaction, parental satisfaction and cost analysis will also be obtained.
- Conditions
- Catheterization, Peripheral Phlebotomy
- Being tested
- Veinviewer, Ultrasound, Conventional technique
- Keywords
- Venipuncture, Randomized Controlled Trial, Intravenous access, Children, Pediatric Emergency Department, Peripheral intravenous catheterization, Catheterization, Peripheral Phlebotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinviewerDevice
Veinviewer machine
UltrasoundDevice
Ultrasound
Conventional techniqueOther
Conventional IV placement by nurses
| Study group | Role | What they receive |
|---|---|---|
| VeinViewer | Active comparator | The Veinviewer machine will be used to guide intravenous access. Receives: Device: Veinviewer |
| Ultrasound | Active comparator | The Ultrasound will be used to guide intravenous access. Receives: Device: Ultrasound |
| Conventional IV placement | Active comparator | IV will be placed using conventional technique Receives: Other: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of peripheral IV placement on first attempt.
The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.
Measured: Within one hour of start of procedure
Secondary outcomes (2)
Number of attempts to successful IV placement
The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.
Measured: Within one hour of start of procedure
Time to successful placement of IV
The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.
Measured: Within one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Curtis, University of Alberta
- Investigators
- Sarah J Curtis, MD, Principal investigator, Division of Pediatric Emergency Medicine, Department of Pediatrics & Women and Children's Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133652
- Sponsor's protocol ID
- Pro00004389
- Other IDs
- G049000062
- Acronym
- VISION
- Status last verified
- Aug 2012
- First submitted
- 18 May 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Curtis SJ, Craig WR, Logue E, Vandermeer B, Hanson A, Klassen T. Ultrasound or near-infrared vascular imaging to guide peripheral intravenous catheterization in children: a pragmatic randomized controlled trial. CMAJ. 2015 May 19;187(8):563-570. doi: 10.1503/cmaj.141012. Epub 2015 Apr 20.
PubMed 25897047
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VISION STUDY: Variation In Success of Intravenous (IV) Placement With Observation Using New Techniques
- ClinicalTrials.gov ID
- NCT01133652
- Acronym / sponsor ID
- VISION / Pro00004389
- Conditions
- Catheterization, Peripheral Phlebotomy
- Keywords
- Venipuncture, Randomized Controlled Trial, Intravenous access, Children, Pediatric Emergency Department, Peripheral intravenous catheterization, Catheterization, Peripheral Phlebotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 May 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.
Children fear having an intravenous (IV) needle placed because of the pain that they will experience. The more needle punctures that a child has to endure before the IV is successfully placed, the greater the pain experienced and anxiety suffered. In addition, false starts increase the demands on medical staff and can increase the length of the emergency department stay. Often, veins are difficult to see or feel, particularly in an unwell, dehydrated child or in young infants who have more fat below the skin surface. Also, the venous pattern below the skin surface naturally varies from person to person and therefore success in placing IVs leaves room for improvement. Technology may be able to play an important role is improving the rates of success. The investigators wish to investigate whether the use of either an Ultrasound machine or a VeinViewer machine can improve the rate of success of the initial attempt (skin puncture) at peripheral IV placement in comparison to the current standard approach.
Detailed description
Peripheral IV line placement is one of the most common and challenging painful procedures performed in the pediatric emergency department (PED). The lack of a clear visual guide for IV placement often leads to multiple painful attempts; delays in urgent treatment; increased use of human resources; increased costs; and increased anxiety in the patient, the parents and the staff. The research plan is a randomized controlled trial (RCT) to compare the use of two new technologies with the current standard method for vein location and IV placement in children.We would like to know if either of these technologies improve rates of successful IV placement on first attempt. Furthermore we would like to know if either technology leads to decreased time spent by staff on the procedure or decreased overall number of painful attempts. Information on nursing satisfaction, parental satisfaction and cost analysis will also be obtained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VeinViewer | Active comparator | Device: VeinviewerThe Veinviewer machine will be used to guide intravenous access. |
| Ultrasound | Active comparator | Device: UltrasoundThe Ultrasound will be used to guide intravenous access. |
| Conventional IV placement | Active comparator | Other: Conventional techniqueIV will be placed using conventional technique |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children 0-16 presenting to the Pediatric Emergency Department (PED)
- Require IV as part of routine care
- Knowledge of English language
Key exclusion criteria (3 listed)
- Child in critical condition
- Child requires urgent IV placement
- Central line available
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 |
|---|---|---|
| VeinviewerVeinviewer machine | Device | VeinViewer |
| UltrasoundUltrasound | Device | Ultrasound |
| Conventional techniqueConventional IV placement by nurses | Other | Conventional IV placement |
Primary outcome
Success or failure of peripheral IV placement on first attempt.
Time frame: Within one hour of start of procedure
The time to placement of a successful intravenous catheter is variable but is generally completed within one hour. This is an estimated timeframe.
2 secondary outcomes
Number of attempts to successful IV placement
Time frame: Within one hour of start of procedure
Time to successful placement of IV
Time frame: Within one hour
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 24 Aug 2012.
- Derived from this study: PubMed 25897047Curtis SJ, Craig WR, Logue E, Vandermeer B, Hanson A, Klassen T. Ultrasound or near-infrared vascular imaging to guide peripheral intravenous catheterization in children: a pragmatic randomized controlled trial. CMAJ. 2015 May 19;187(8):563-570. doi: 10.1503/cmaj.141012. Epub 2015 Apr 20.
Related trials for Catheterization
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Novel Wearable Device for Heart Failure Management
Heart Failure
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
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.
Sarah J Curtis, MD principal investigator
Division of Pediatric Emergency Medicine, Department of Pediatrics & Women and Children's Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Veinviewer, Ultrasound and Conventional technique in people with Catheterization and Peripheral Phlebotomy, run by University of Alberta at 1 site in Canada.
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 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 24 Aug 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success or failure of peripheral IV placement on first attempt. (time frame: Within one hour of start of procedure). 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 NCT01133652, 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 24 Aug 2012.