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

U

University of Indonesia (UI)

Status

Completed

Conditions

Difficult Vein Access

Treatments

Device: Vein Display Instrument

Study type

Interventional

Funder types

Other

Identifiers

NCT03134560
IndonesiaUAnes003

Details and patient eligibility

About

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

Full 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.

Enrollment

88 patients

Sex

All

Ages

Under 5 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

88 participants in 2 patient groups

With vein display instrument
Active Comparator group
Description:
Vein cannulation was done after the vein display instrument displays the veins using infrared
Treatment:
Device: Vein Display Instrument
Without vein display instrument
No Intervention group
Description:
vein cannulation was done without any vein display instrument

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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