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

NCT03134560 | Completed

• 1 other identifier: IndonesiaUAnes003
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Difficult Vein Access

Keywords

vein display instrument; pediatric; vein access; vein cannulation

Outcome Measures

Primary Outcomes (1)

• Successful first vein cannulation attempt

  Whether the first vein cannulation attempt successful or not will be recorded

  Day 1

Study Arms (2)

With vein display instrument

ACTIVE COMPARATOR

Vein cannulation was done after the vein display instrument displays the veins using infrared

Device: Vein Display Instrument

Without vein display instrument

NO INTERVENTION

vein cannulation was done without any vein display instrument

Interventions

Vein Display Instrument DEVICE

With vein display instrument

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, 10430, Indonesia

Location

Related Publications (13)

• 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.

  PMID: 23952007 BACKGROUND

• 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.

  PMID: 16134420 BACKGROUND

• 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.

  PMID: 19262420 BACKGROUND

• 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.

  PMID: 18931210 BACKGROUND

• 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.

  PMID: 21854488 BACKGROUND

• 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.

  PMID: 22967159 BACKGROUND

• Donaldson JS. Pediatric vascular access. Pediatr Radiol. 2006 May;36(5):386-97. doi: 10.1007/s00247-006-0118-1. Epub 2006 Mar 15.

  PMID: 16538464 BACKGROUND

• 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.

  PMID: 23258720 BACKGROUND

• 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.

  PMID: 23687310 BACKGROUND

• 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.

  PMID: 22415409 BACKGROUND

• 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.

  PMID: 23384732 BACKGROUND

• 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.

  PMID: 22694242 BACKGROUND

• 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.

  PMID: 17238901 BACKGROUND

Study Officials

• Aries Perdana, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Anesthesiologist

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 1, 2017
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

ID (1)