CatheterizationNCT05242068
Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children
A study testing Veinlite in people with Catheterization and Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Catheterization, Pain, Complication
- What is being tested?
- Veinlite
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 5 Jan 2020
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged between 5 and 18
- Children with DIVA (Difficult intravenous access score) score 4 or more
- That the child and the parent speak Turkish
Who cannot join
- needing urgent treatment
- a critical health condition
- That the child or the parent has a communication problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children: Preliminary Results.
This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood.
The investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.
Read the detailed description
Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential morbidities. Patients with PIC-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. The most serious complications due to intravenous (IV) catheters are infiltration and extravasation.
The primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related complications.
The secondary endpoint were;
- to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization
- to evaluate the efficacy of the vein imaging device on catheter dwell time.
- Conditions
- Catheterization, Pain, Complication
- Being tested
- Veinlite, Standard care
- Keywords
- pain, children, vein imaging device, intravenous complications
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinliteDevice
Use of vein imaging device for visualization of veins during peripheral IV placement
Standard careOther
Patients received standard intravenous catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Standard care of group | Other | Patients in standard care of group received traditional peripheral intravenous catheterization Receives: Other: Standard care |
| Veinlite group | Experimental | Patients in veinlite group received peripheral intravenous catheterization with Veinlite Receives: Device: Veinlite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing number of complications related with peripheral intravenous catheter
Reducing number of complications related with peripheral intravenous catheter during treatment
Measured: Duration of catheter dwell time (up to 168 hours)
Secondary outcomes (2)
Pain scores during peripheral intravenous catheterization
Pain scores by child, nurse, and parent. In this study, numerical rating score was used for determine pain level. The numeric rating scale is one of the most commonly used to obtain self-reports of pain intensity in school-age children, adolescents, and adults. The numerical rating scale (NRS) requires the child to rate her/his pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: Immediately after IV placement
Catheter dwell time
Intravenous catheter survival time during the treatment
Measured: Up to 168 hours (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Dec 2018
- Primary completion6 Aug 2019
- Study completion5 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- More trials run by Ege 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a prospective randomized controlled clinical study of children treated in a pediatric surgical ward who required PIC. The aim of the research was to evaluate whether the Veinlite would prevent catheter-related complications
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Kahraman, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242068
- Sponsor's protocol ID
- E.314064
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children: Preliminary Results.
- ClinicalTrials.gov ID
- NCT05242068
- Acronym / sponsor ID
- E.314064
- Conditions
- Catheterization, Pain, Complication
- Keywords
- pain, children, vein imaging device, intravenous complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 5 Jan 2020 (actual)
- First posted
- 16 Feb 2022 (actual)
- 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.
This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood.
The investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.
Detailed description
Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential morbidities. Patients with PIC-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. The most serious complications due to intravenous (IV) catheters are infiltration and extravasation.
The primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related complications.
The secondary endpoint were;
- to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization
- to evaluate the efficacy of the vein imaging device on catheter dwell time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a prospective randomized controlled clinical study of children treated in a pediatric surgical ward who required PIC. The aim of the research was to evaluate whether the Veinlite would prevent catheter-related complications
| Arm | Type | Receives |
|---|---|---|
| Standard care of group | Other | Other: Standard carePatients in standard care of group received traditional peripheral intravenous catheterization |
| Veinlite group | Experimental | Device: VeinlitePatients in veinlite group received peripheral intravenous catheterization with Veinlite |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged between 5 and 18
- Children with DIVA (Difficult intravenous access score) score 4 or more
- That the child and the parent speak Turkish
Key exclusion criteria (3 listed)
- needing urgent treatment
- a critical health condition
- That the child or the parent has a communication problem
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 |
|---|---|---|
| VeinliteUse of vein imaging device for visualization of veins during peripheral IV placement | Device | Veinlite group |
| Standard carePatients received standard intravenous catheterization. | Other | Standard care of group |
Primary outcome
Reducing number of complications related with peripheral intravenous catheter
Time frame: Duration of catheter dwell time (up to 168 hours)
Reducing number of complications related with peripheral intravenous catheter during treatment
2 secondary outcomes
Pain scores during peripheral intravenous catheterization
Time frame: Immediately after IV placement
Catheter dwell time
Time frame: Up to 168 hours (1 week)
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 16 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veinlite in people with Catheterization and Pain, run by Ege University at 1 site in Turkey (Türkiye).
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 16 Feb 2022. 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 Turkey (Türkiye). 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?
Reducing number of complications related with peripheral intravenous catheter (time frame: Duration of catheter dwell time (up to 168 hours)). 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 16 Feb 2022.