Successful Vein Cannulation at First AttemptNCT02918604
Pediatric Veins Cannulation Technique
A study testing infrared technology: Veinsite in people with Successful Vein Cannulation at First Attempt, run by Bambino Gesù Hospital and Research Institute.
Trial summary
multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children. Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Successful Vein Cannulation at First Attempt
- What is being tested?
- infrared technology: Veinsite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and Female children from 1 month to 5 years Of age
- American Society of Anesthesiologists Classification (ASA) I: without systemic disease
- American Society of Anesthesiologists Classification (ASA) II: moderate systemic disease
- American Society of Anesthesiologists Classification (ASA) III: severe systemic disease that limits normal activity, without invalidity.
- Scheduled for any indication of peripheral venous line placement
- Admission to an Intensive Care Unit, Neurosurgery ward or pediatric ward of one of the hospitals included
- Children whose parents (or legal tutors) have given their informed written consent
Who cannot join
- Any contraindication for peripheral line placement
- Children whose parents (or legal tutors) denied their own consensus
About this study
Official title: Peripheral Veins Cannulation in Children Using Veinsite: a Randomized Clinical Trial
multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.
Read the detailed description
AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.
The secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure.
DESIGN Prospective randomized controlled study
Population
It is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers:
- Fondazione IRCCS Istituto Neurologico "C.Besta" , Milano
- Ospedale Pediatrico Bambino Gesù, IRCCS, Roma
Duration of study Patient will be followed from the day of peripheral vein cannulation till the peripheral cannula will be removed (max 3 days) in order to assess any cause of venous extravasation. The recruitment phase is supposed to be 6 months after achieving the ethical-administrative authorization.
- Being tested
- infrared technology: Veinsite
- Keywords
- peripheral vein access, infrared, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared technology: VeinsiteDevice
peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists
| Study group | Role | What they receive |
|---|---|---|
| B : veinsite access | Other | infrared technology vein access Receives: Device: infrared technology: Veinsite |
| A: control group | Active comparator | conventional vein access Receives: Device: infrared technology: Veinsite |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of peripheral vein access positioning
to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.
Measured: 2 year
Secondary outcomes (1)
impact of DIVA score(difficult vein access score) on time of success number of participants with treatment-related peripheral vein cannulation failure
of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Successful Vein Cannulation at First AttemptStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Rossetti, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918604
- Sponsor's protocol ID
- AR-INNCB 11-2013
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Reigart JR, Chamberlain KH, Eldridge D, O'Brien ES, Freeland KD, Larsen P, Goff D, Hartzog TH. Peripheral intravenous access in pediatric inpatients. Clin Pediatr (Phila). 2012 May;51(5):468-72. doi: 10.1177/0009922811435164. Epub 2012 Jan 20.
PubMed 22267855Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.
PubMed 21854488Kim MJ, Park JM, Rhee N, Je SM, Hong SH, Lee YM, Chung SP, Kim SH. Efficacy of VeinViewer in pediatric peripheral intravenous access: a randomized controlled trial. Eur J Pediatr. 2012 Jul;171(7):1121-5. doi: 10.1007/s00431-012-1713-9. Epub 2012 Mar 14.
PubMed 22415409Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.
PubMed 18347490
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Veins Cannulation in Children Using Veinsite: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02918604
- Acronym / sponsor ID
- AR-INNCB 11-2013
- Keywords
- peripheral vein access, infrared, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Sep 2016 (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.
multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.
Detailed description
AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.
The secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure.
DESIGN Prospective randomized controlled study
Population
It is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers:
- Fondazione IRCCS Istituto Neurologico "C.Besta" , Milano
- Ospedale Pediatrico Bambino Gesù, IRCCS, Roma
Duration of study Patient will be followed from the day of peripheral vein cannulation till the peripheral cannula will be removed (max 3 days) in order to assess any cause of venous extravasation. The recruitment phase is supposed to be 6 months after achieving the ethical-administrative authorization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B : veinsite access | Other | Device: infrared technology: Veinsiteinfrared technology vein access |
| A: control group | Active comparator | Device: infrared technology: Veinsiteconventional vein access |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male and Female children from 1 month to 5 years Of age
- American Society of Anesthesiologists Classification (ASA) I: without systemic disease
- American Society of Anesthesiologists Classification (ASA) II: moderate systemic disease
- American Society of Anesthesiologists Classification (ASA) III: severe systemic disease that limits normal activity, without invalidity.
- Scheduled for any indication of peripheral venous line placement
Key exclusion criteria (2 listed)
- Any contraindication for peripheral line placement
- Children whose parents (or legal tutors) denied their own consensus
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 |
|---|---|---|
| infrared technology: Veinsiteperipheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists | Device | A: control group, B : veinsite access |
Primary outcome
success of peripheral vein access positioning
Time frame: 2 year
to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.
1 secondary outcome
impact of DIVA score(difficult vein access score) on time of success number of participants with treatment-related peripheral vein cannulation failure
Time frame: 2 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 29 Sep 2016.
- Background: PubMed 22267855Reigart JR, Chamberlain KH, Eldridge D, O'Brien ES, Freeland KD, Larsen P, Goff D, Hartzog TH. Peripheral intravenous access in pediatric inpatients. Clin Pediatr (Phila). 2012 May;51(5):468-72. doi: 10.1177/0009922811435164. Epub 2012 Jan 20.
- Background: PubMed 21854488Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.
- Background: PubMed 22415409Kim MJ, Park JM, Rhee N, Je SM, Hong SH, Lee YM, Chung SP, Kim SH. Efficacy of VeinViewer in pediatric peripheral intravenous access: a randomized controlled trial. Eur J Pediatr. 2012 Jul;171(7):1121-5. doi: 10.1007/s00431-012-1713-9. Epub 2012 Mar 14.
- Background: PubMed 18347490Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing infrared technology: Veinsite in people with Successful Vein Cannulation at First Attempt, run by Bambino Gesù Hospital and Research Institute.
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 7 inclusion and 2 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
success of peripheral vein access positioning (time frame: 2 year). 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 NCT02918604, which also lists 4 linked publications.
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 29 Sep 2016.