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

NCT ID: NCT03134560

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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

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Difficult Vein Access

Keywords

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vein display instrument pediatric vein access vein cannulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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With vein display instrument

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

Group Type ACTIVE_COMPARATOR

Vein Display Instrument

Intervention Type DEVICE

Without vein display instrument

vein cannulation was done without any vein display instrument

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vein Display Instrument

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Aries Perdana

Consultant, Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aries Perdana, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 23952007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16134420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19262420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18931210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21854488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22967159 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 16538464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23258720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23687310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22415409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23384732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22694242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17238901 (View on PubMed)

Study Documents

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Document Type: Textbook

View Document

Other Identifiers

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IndonesiaUAnes003

Identifier Type: -

Identifier Source: org_study_id