Difficult Vein AccessNCT03134560

Intravenous Cannulation Using Vein Display Instrument and Without Using Vein Display Instrument in Pediatric Patients

A study testing Vein Display Instrument in people with Difficult Vein Access, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients. Read more about this study

Who is it for?: Ages Up to 5 years
Conditions the study is for: Difficult Vein Access
What is being tested?: Vein Display Instrument
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteIndonesia
Study dates: Apr 2016to 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 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subjects aged 0-5 years old
Subjects with difficult vein access (e.g. edema, obesity, chemotherapy history),
Subjects whose parents had signed the informed consent
Subjects with available vein access locations at the back of either hands.

Who cannot join

Subjects who had infection signs at the designated vein access location
Subjects in need of emergency procedures.
Drop out Criteria:
Subjects resigned from the study
Subjects rejected any next attempt of intravenous cannulation
Subjects who received anesthetic drugs before intravenous cannulation.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Cipto Mangunkusumo Central National Hospital
Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Comparison Between Using Vein Display Instrument and Without Using Vein Display Instrument for Successful Intravenous Cannulation in Pediatric Patients

This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients.

Read the detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Parents' subjects were given informed consent before enrolling the study. After doing asepsis and antisepsis procedure and putting on the tourniquet the first group would get intravenous cannulation without vein displaying instrument. While for the second group, after doing asepsis procedure and tourniquet was put on, a vein display instrument was used to choose the vein. Intravenous cannulation was done after antiseptic procedure. After blood dripped out of the cannula, cannula was connected to the infusion set. Evaluation was done to assess vein route establishment, canulation attempt number and swelling. Data recorded were analyzed using Statistical Package for the Social Sciences (SPSS) using Chi-square test or Fisher Exact test. Significant value is p<0.05.

Conditions: Difficult Vein Access
Being tested: Vein Display Instrument
Keywords: vein display instrument, pediatric, vein access, vein cannulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vein Display InstrumentDevice

Study groups in NCT03134560
Study group	Role	What they receive
With vein display instrument	Active comparator	Vein cannulation was done after the vein display instrument displays the veins using infrared Receives: Device: Vein Display Instrument
Without vein display instrument	No intervention	vein cannulation was done without any vein display instrument

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful first vein cannulation attempt
Whether the first vein cannulation attempt successful or not will be recorded
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016May 2016

First posted1 May 2017
Study startApr 2016
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Difficult Vein AccessStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03134560
Sponsor's protocol ID: IndonesiaUAnes003
Status last verified: Oct 2017
First submitted: 24 Apr 2017
Last updated: 30 Oct 2017
Results posted: No
Individual data sharing: Undecided

Publications

Myers LA, Arteaga GM, Kolb LJ, Lohse CM, Russi CS. Prehospital peripheral intravenous vascular access success rates in children. Prehosp Emerg Care. 2013 Oct-Dec;17(4):425-8. doi: 10.3109/10903127.2013.818180. Epub 2013 Aug 16.
PubMed 23952007
Scales K. Vascular access: a guide to peripheral venous cannulation. Nurs Stand. 2005 Aug 17-23;19(49):48-52. doi: 10.7748/ns2005.08.19.49.48.c3935.
PubMed 16134420
Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
PubMed 19262420
Simhi E, Kachko L, Bruckheimer E, Katz J. A vein entry indicator device for facilitating peripheral intravenous cannulation in children: a prospective, randomized, controlled trial. Anesth Analg. 2008 Nov;107(5):1531-5. doi: 10.1213/ane.0b013e318185cdab.
PubMed 18931210
Chapman 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 21854488
Schindler E, Schears GJ, Hall SR, Yamamoto T. Ultrasound for vascular access in pediatric patients. Paediatr Anaesth. 2012 Oct;22(10):1002-7. doi: 10.1111/pan.12005.
PubMed 22967159
Donaldson JS. Pediatric vascular access. Pediatr Radiol. 2006 May;36(5):386-97. doi: 10.1007/s00247-006-0118-1. Epub 2006 Mar 15.
PubMed 16538464
de Negri DC, Avelar AF, Andreoni S, Pedreira Mda L. Predisposing factors for peripheral intravenous puncture failure in children. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1072-80. doi: 10.1590/s0104-11692012000600009. English, Portuguese, Spanish.
PubMed 23258720
Lamperti M, Pittiruti M. II. Difficult peripheral veins: turn on the lights. Br J Anaesth. 2013 Jun;110(6):888-91. doi: 10.1093/bja/aet078. No abstract available.
PubMed 23687310
Kim 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 22415409
Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.
PubMed 23384732
Kaddoum RN, Anghelescu DL, Parish ME, Wright BB, Trujillo L, Wu J, Wu Y, Burgoyne LL. A randomized controlled trial comparing the AccuVein AV300 device to standard insertion technique for intravenous cannulation of anesthetized children. Paediatr Anaesth. 2012 Sep;22(9):884-9. doi: 10.1111/j.1460-9592.2012.03896.x. Epub 2012 Jun 14.
PubMed 22694242
John JM. Transillumination for vascular access: old concept, new technology. Paediatr Anaesth. 2007 Feb;17(2):197-8. doi: 10.1111/j.1460-9592.2006.02061.x. No abstract available.
PubMed 17238901

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound

All Difficult Vein Access trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Using Vein Display Instrument and Without Using Vein Display Instrument for Successful Intravenous Cannulation in Pediatric Patients
ClinicalTrials.gov ID: NCT03134560
Acronym / sponsor ID: IndonesiaUAnes003
Conditions: Difficult Vein Access
Keywords: vein display instrument, pediatric, vein access, vein cannulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: Apr 2016
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 1 May 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.

This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
With vein display instrument	Active comparator	Device: Vein Display InstrumentVein cannulation was done after the vein display instrument displays the veins using infrared
Without vein display instrument	No intervention	–vein cannulation was done without any vein display instrument

Who may qualify

Ages: Up to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subjects aged 0-5 years old
Subjects with difficult vein access (e.g. edema, obesity, chemotherapy history),
Subjects whose parents had signed the informed consent
Subjects with available vein access locations at the back of either hands.

Key exclusion criteria (6 listed)

Subjects who had infection signs at the designated vein access location
Subjects in need of emergency procedures.
Subjects resigned from the study
Subjects rejected any next attempt of intravenous cannulation
Subjects who received anesthetic drugs before intravenous cannulation.

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
Vein Display Instrument	Device	With vein display instrument

Primary outcome

Successful first vein cannulation attempt
Time frame: Day 1
Whether the first vein cannulation attempt successful or not will be recorded

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 Oct 2017.
Background: PubMed 23952007Myers LA, Arteaga GM, Kolb LJ, Lohse CM, Russi CS. Prehospital peripheral intravenous vascular access success rates in children. Prehosp Emerg Care. 2013 Oct-Dec;17(4):425-8. doi: 10.3109/10903127.2013.818180. Epub 2013 Aug 16.
Background: PubMed 16134420Scales K. Vascular access: a guide to peripheral venous cannulation. Nurs Stand. 2005 Aug 17-23;19(49):48-52. doi: 10.7748/ns2005.08.19.49.48.c3935.
Background: PubMed 19262420Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
Background: PubMed 18931210Simhi E, Kachko L, Bruckheimer E, Katz J. A vein entry indicator device for facilitating peripheral intravenous cannulation in children: a prospective, randomized, controlled trial. Anesth Analg. 2008 Nov;107(5):1531-5. doi: 10.1213/ane.0b013e318185cdab.
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 22967159Schindler E, Schears GJ, Hall SR, Yamamoto T. Ultrasound for vascular access in pediatric patients. Paediatr Anaesth. 2012 Oct;22(10):1002-7. doi: 10.1111/pan.12005.
Background: PubMed 16538464Donaldson JS. Pediatric vascular access. Pediatr Radiol. 2006 May;36(5):386-97. doi: 10.1007/s00247-006-0118-1. Epub 2006 Mar 15.
Background: PubMed 23258720de Negri DC, Avelar AF, Andreoni S, Pedreira Mda L. Predisposing factors for peripheral intravenous puncture failure in children. Rev Lat Am Enfermagem. 2012 Nov-Dec;20(6):1072-80. doi: 10.1590/s0104-11692012000600009. English, Portuguese, Spanish.
Background: PubMed 23687310Lamperti M, Pittiruti M. II. Difficult peripheral veins: turn on the lights. Br J Anaesth. 2013 Jun;110(6):888-91. doi: 10.1093/bja/aet078. No abstract available.
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 23384732Chiao FB, Resta-Flarer F, Lesser J, Ng J, Ganz A, Pino-Luey D, Bennett H, Perkins C Jr, Witek B. Vein visualization: patient characteristic factors and efficacy of a new infrared vein finder technology. Br J Anaesth. 2013 Jun;110(6):966-71. doi: 10.1093/bja/aet003. Epub 2013 Feb 5.
Background: PubMed 22694242Kaddoum RN, Anghelescu DL, Parish ME, Wright BB, Trujillo L, Wu J, Wu Y, Burgoyne LL. A randomized controlled trial comparing the AccuVein AV300 device to standard insertion technique for intravenous cannulation of anesthetized children. Paediatr Anaesth. 2012 Sep;22(9):884-9. doi: 10.1111/j.1460-9592.2012.03896.x. Epub 2012 Jun 14.
Individual participant dataSharing planned: Undecided

Related trials for Difficult Vein Access

Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Active, not recruitingObservational study
A New Landmark-formula for Cephalic Vein in Children
Venipuncture, Ultrasound

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.

Aries Perdana, Consultant principal investigator

Universitas Indonesia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vein Display Instrument in people with Difficult Vein Access, run by Universitas Indonesia at 1 site in Indonesia.

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 4 inclusion and 6 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 Oct 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 Indonesia. 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?

Successful first vein cannulation attempt (time frame: Day 1). 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 NCT03134560, which also lists 13 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 30 Oct 2017.