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

Not Applicable

Completed

• Conditions: Difficult Vein Access
• Interventions: Device: Vein Display Instrument

• Registration Number: NCT03134560
• Lead Sponsor: Indonesia University

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.

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.

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With vein display instrument	Vein Display Instrument	Vein cannulation was done after the vein display instrument displays the veins using infrared

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta, Indonesia