Blood Drawing ProcedureNCT03277092
Near Infrared Light in Paediatric Blood Drawing Centre
A study testing VeinViewer® in people with Blood Drawing Procedure, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Blood Drawing Procedure
- What is being tested?
- VeinViewer®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2017to 28 Nov 2017
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects accessing the outpatient blood-drawing service
Who cannot join
- application of topical anaesthetic cream
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure
Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.
The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.
- Conditions
- Blood Drawing Procedure
- Being tested
- VeinViewer®, Usual care
- Keywords
- Child, blood drawing procedure, near Infrared light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinViewer®Device
Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site
Usual careProcedure or surgery
The blood drawing is performed traditionally
| Study group | Role | What they receive |
|---|---|---|
| VeinViewer® group | Experimental | Use of near infrared light to perform blood draw (VeinViewer®) Receives: Device: VeinViewer® |
| Usual care group | Active comparator | Blood drawing performed traditionally Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to perform the procedure
In seconds, from the placement of the tourniquet until the blood flows in the needle
Measured: Intraprocedural
Secondary outcomes (1)
Success at first attempt
Percentage of success at first attempt
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start2 Oct 2017
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
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 Blood Drawing ProcedureStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egidio Barbi, MD PhD, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277092
- Sponsor's protocol ID
- RC 22/17
- Status last verified
- Jun 2017
- First submitted
- 7 Sep 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conversano E, Cozzi G, Pavan M, Minute M, Gortan E, Montico M, Vecchi Brumatti L, Ronfani L, Barbi E. Impact of near infrared light in pediatric blood drawing Centre on rate of first attempt success and time of procedure. Ital J Pediatr. 2018 May 25;44(1):60. doi: 10.1186/s13052-018-0501-1.
PubMed 29801519
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure
- ClinicalTrials.gov ID
- NCT03277092
- Acronym / sponsor ID
- RC 22/17
- Conditions
- Blood Drawing Procedure
- Keywords
- Child, blood drawing procedure, near Infrared light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 8 Sep 2017 (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.
Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.
The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VeinViewer® group | Experimental | Device: VeinViewer®Use of near infrared light to perform blood draw (VeinViewer®) |
| Usual care group | Active comparator | Procedure: Usual careBlood drawing performed traditionally |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- subjects accessing the outpatient blood-drawing service
Key exclusion criteria (1 listed)
- application of topical anaesthetic cream
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 |
|---|---|---|
| VeinViewer®Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site | Device | VeinViewer® group |
| Usual careThe blood drawing is performed traditionally | Procedure or surgery | Usual care group |
Primary outcome
Time to perform the procedure
Time frame: Intraprocedural
In seconds, from the placement of the tourniquet until the blood flows in the needle
1 secondary outcome
Success at first attempt
Time frame: Intraprocedural
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 30 Nov 2017.
- Derived from this study: PubMed 29801519Conversano E, Cozzi G, Pavan M, Minute M, Gortan E, Montico M, Vecchi Brumatti L, Ronfani L, Barbi E. Impact of near infrared light in pediatric blood drawing Centre on rate of first attempt success and time of procedure. Ital J Pediatr. 2018 May 25;44(1):60. doi: 10.1186/s13052-018-0501-1.
- 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.
Egidio Barbi, MD PhD principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeinViewer® in people with Blood Drawing Procedure, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 30 Nov 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 Italy. 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?
Time to perform the procedure (time frame: Intraprocedural). 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 NCT03277092, 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 30 Nov 2017.