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

Difficult Vein Access Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134560
• Other study ID #: IndonesiaUAnes003
• Status: Completed
• Phase: N/A
• First received: April 24, 2017
• Last updated: October 26, 2017
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: October 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Difficult Vein Access

Intervention

Device:
• Vein Display Instrument

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. English, Portuguese, Spanish. — View Citation

Donaldson JS. Pediatric vascular access. Pediatr Radiol. 2006 May;36(5):386-97. Epub 2006 Mar 15. Review. — View Citation

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. — View Citation

John JM. Transillumination for vascular access: old concept, new technology. Paediatr Anaesth. 2007 Feb;17(2):197-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Scales K. Vascular access: a guide to peripheral venous cannulation. Nurs Stand. 2005 Aug 17-23;19(49):48-52. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful first vein cannulation attempt	Whether the first vein cannulation attempt successful or not will be recorded	Day 1

External Links

•   Varma R, Sahane SD, Thakre SS. Infrared Vein viewer.