Peripheral Venous CatheterizationNCT02265380
A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
A study testing Placement of IV catheter in people with Peripheral Venous Catheterization, run by Optomeditech Oy at 1 site in Finland.
Trial summary
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Peripheral Venous Catheterization
- What is being tested?
- Placement of IV catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2014to 25 Aug 2016
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged newborn to 12 years
- Has written or verbal order for insertion of an IV
- Requires peripheral IV therapy (catheter)
- Has an insertion site in the hand, forearm, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the study protocol
Who cannot join
- In the newborn nursery or intensive care units (neonatal or pediatric)
- On patient-controlled analgesia pump
- Patient is anesthetized
- Terminally ill
- Transferred from the operating room less than 8 hours postanasthesia
- Any child the research staff deem unobservable
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- The study IV catheter site will be placed below an old infusion site
- The study IV site needs to be immobilized with a splint or other devices
- Has or has had a previous IV catheter related phlebitis or infiltration during current hospitalization
- Will require a power injection for a radiologic procedure during participation in this study
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki and Uusimaa Hospital District, Children's Hospital
Helsinki, 00029
About this study
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.
Read the detailed description
The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The electronic unit is a portable internally powered generator of low power visible laser light of green color. The electronic unit generates visible light, which is released from the tip of the needle into the soft tissue around the tip of the IV catheter. Light is visible through the skin and helps mark the location of the tip of the needle under the skin and against the vein.
In addition to pinpointing the exact location of the tip of the needle, the OptiVein System informs the user of the exact moment of penetration of the tip of the needle into the blood vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when the needle enters the blood vessel, the light is instantly absorbed by blood, which causes instant fading of skin transillumination. Instant disappearance of tissue illumination indicates successful venipuncture. The user can then lower the angle of the needle and start to advance the cannula over the needle into the blood vessel. Such optical confirmation is much faster than the traditional observation of blood in the flashback chamber of the needle and should lead to increased first-attempt success rates and decreased cannulation-related complications.
The use of OptiVein device will be compared to the use of a traditional IV catheter to explore the potential increase of effectiveness of cannulation with OptiVein versus traditional IV catheters.
- Conditions
- Peripheral Venous Catheterization
- Being tested
- Placement of IV catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of IV catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment with OptiVein | Experimental | The patient will have an IV catheter placed with the use of OptiVein device. Receives: Device: Placement of IV catheter |
| Treatment with Vasofix Certo | Active comparator | The patient will have an IV catheter placed with the use of Vasofix Certo device. Receives: Device: Placement of IV catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful IV insertion on the first attempt
Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
Measured: Immediate
Secondary outcomes (6)
Total number of attempts required for successful IV insertion
Measured: Immediate
Time to successful IV insertion
Defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
Measured: Immediate
Incidence of blood extravasation resulting in a hematoma
Measured: Up to 72 hours
Incidence of fluid extravasation delivered through catheter
Measured: Up to 72 hours
Incidence of infection (phlebitis, dermatitis and induration)
Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
Measured: Up to 72 hours
Unplanned withdrawal of IV catheter
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion25 Aug 2016
- Study completion25 Aug 2016
Why it stopped: Inability to recruit patients sufficiently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Venous CatheterizationStudies 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
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optomeditech Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital District of Helsinki and Uusimaa, CardioMed Device Consultants, LLC
- Responsible party
- Sponsor
- Investigators
- Tomi Taivainen, MD, PhD, Principal investigator, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265380
- Sponsor's protocol ID
- OMT-CT-002-PED
- Status last verified
- Feb 2017
- First submitted
- 9 Oct 2014
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
- ClinicalTrials.gov ID
- NCT02265380
- Acronym / sponsor ID
- OMT-CT-002-PED
- Conditions
- Peripheral Venous Catheterization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit patients sufficiently
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Optomeditech OyIndustry (pharma, biotech, devices)
- Collaborators
- Hospital District of Helsinki and Uusimaa, CardioMed Device Consultants, LLC
- Study start
- Oct 2014
- Primary completion
- 25 Aug 2016 (actual)
- Study completion
- 25 Aug 2016 (actual)
- First posted
- 15 Oct 2014 (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.
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.
Detailed description
The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The electronic unit is a portable internally powered generator of low power visible laser light of green color. The electronic unit generates visible light, which is released from the tip of the needle into the soft tissue around the tip of the IV catheter. Light is visible through the skin and helps mark the location of the tip of the needle under the skin and against the vein.
In addition to pinpointing the exact location of the tip of the needle, the OptiVein System informs the user of the exact moment of penetration of the tip of the needle into the blood vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when the needle enters the blood vessel, the light is instantly absorbed by blood, which causes instant fading of skin transillumination. Instant disappearance of tissue illumination indicates successful venipuncture. The user can then lower the angle of the needle and start to advance the cannula over the needle into the blood vessel. Such optical confirmation is much faster than the traditional observation of blood in the flashback chamber of the needle and should lead to increased first-attempt success rates and decreased cannulation-related complications.
The use of OptiVein device will be compared to the use of a traditional IV catheter to explore the potential increase of effectiveness of cannulation with OptiVein versus traditional IV catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with OptiVein | Experimental | Device: Placement of IV catheterThe patient will have an IV catheter placed with the use of OptiVein device. |
| Treatment with Vasofix Certo | Active comparator | Device: Placement of IV catheterThe patient will have an IV catheter placed with the use of Vasofix Certo device. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged newborn to 12 years
- Has written or verbal order for insertion of an IV
- Requires peripheral IV therapy (catheter)
- Has an insertion site in the hand, forearm, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the study protocol
Key exclusion criteria (10 listed)
- In the newborn nursery or intensive care units (neonatal or pediatric)
- On patient-controlled analgesia pump
- Patient is anesthetized
- Terminally ill
- Transferred from the operating room less than 8 hours postanasthesia
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 |
|---|---|---|
| Placement of IV catheter | Device | Treatment with OptiVein, Treatment with Vasofix Certo |
Primary outcome
Successful IV insertion on the first attempt
Time frame: Immediate
Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
6 secondary outcomes
Total number of attempts required for successful IV insertion
Time frame: Immediate
Time to successful IV insertion
Time frame: Immediate
Incidence of blood extravasation resulting in a hematoma
Time frame: Up to 72 hours
Incidence of fluid extravasation delivered through catheter
Time frame: Up to 72 hours
Incidence of infection (phlebitis, dermatitis and induration)
Time frame: Up to 72 hours
Unplanned withdrawal of IV catheter
Time frame: Up to 72 hours
Results and safety
The study was stopped early (reason given: Inability to recruit patients sufficiently). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
Tomi Taivainen, MD, PhD principal investigator
Hospital District of Helsinki and Uusimaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of IV catheter in people with Peripheral Venous Catheterization, run by Optomeditech Oy at 1 site in Finland.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Mar 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 Finland. 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 was stopped early (reason given: Inability to recruit patients sufficiently). Results are not available in the source record.
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 insertion on the first attempt (time frame: Immediate). 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 1 Mar 2017.