NCT06233214

Brief Summary

Peripheral Intravenous Catheter (PIC) application in pediatric wards of hospitals; It is used in the administration of drugs that require diarrhea, vomiting, dehydration or high serum concentration, resistant infections, parenteral treatments, continuous bolus analgesic needs and emergency treatment situations. Although PIC is a frequently used practice, especially in pediatric emergency departments, it is seen as a difficult approach for healthcare professionals. PIC applications may be more difficult in pediatric patients due to their small vascular structures, the fact that the vessels are surrounded by subcutaneous tissue, and lack of communication. Every child's venous anatomy is different. Therefore, selecting the appropriate vein by ensuring palpation and using appropriate tools before the procedure will reduce the pain and stress the child will experience. Biomedical tools are used to increase success in vascular interventions. Studies have shown that PIC procedure time is shorter in pediatric patients using vein imaging devices and the number of interventions is lower than the control group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

January 31, 2024

Status Verified

December 1, 2023

Enrollment Period

Same day

First QC Date

December 22, 2023

Last Update Submit

January 29, 2024

Conditions

Keywords

pediatricsperipheral intravenous catheter applicationvein imaging device

Outcome Measures

Primary Outcomes (1)

  • Interview and Observation Form

    This form consists of 13 items developed based on the available literature. The first five items question demographic characteristics, and the others question the success of the procedure regarding the number of attempts and their duration.

    it will take approximately 5 minutes to fill out the form.

Secondary Outcomes (1)

  • Difficult Intravenous Access Score

    it will take approximately 1 minutes to fill out the form.

Study Arms (2)

vein imaging device

EXPERIMENTAL

During the PIC application attempt, the parents of the children in the experimental group will be ensured to be with their children throughout the procedure. PIC placement attempt will be performed on the experimental group with the help of a vein imaging device.

Device: vein imaging device

control group

NO INTERVENTION

PIC placement attempt will be performed in the control group using the traditional application method without device support.

Interventions

During the PIC application attempt, the parents of the children in the experimental group will be ensured to be with their children throughout the procedure. PIC placement attempt will be performed on the experimental group with the help of a vein imaging device.

vein imaging device

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The child is between the ages of 6-12,
  • The child is receiving treatment through peripheral vascular access,
  • Parent and child agree to participate in the research,
  • PIK placement is done by the same nurse,
  • PIK placement should be performed with the same catheter number (24-G or 22-G) and brand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Hafsa Sultan Hospital

Manisa, Turkey (Türkiye)

RECRUITING

Study Officials

  • Duygu Karaarslan

    Manisa Celal Bayar University

    STUDY DIRECTOR

Central Study Contacts

Duygu Karaarslan

CONTACT

Abdulkadir Utar

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: PIC placement attempt will be performed with the help of a vein imaging device in the study/experiment group, and with the traditional application method without device support in the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 31, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2024

Study Completion

March 30, 2024

Last Updated

January 31, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations