NCT06579820

Brief Summary

In pediatric patients, placement of peripheral intravenous catheters is the most commonly performed invasive medical procedure. In addition to the administration of medications, parenteral nutrition, intravenous fluids, and blood products, peripheral intravenous catheters are placed prophylactically before procedures and for emergency use in unstable patients. One of the most common complications of peripheral intravenous catheters is infiltration. Infiltration is a vascular trauma resulting from a lesion in the vascular layers and subsequent perforation, resulting in the leakage of medications or non-vesicant solutions into the tissues surrounding the site of placement of the peripheral venous catheter. In pediatric patients, physical factors (e.g. hyperactivity, sweating), tight fixation (may affect blood circulation and iatrogenic skin injury), loose fixation (may cause peripheral intravenous catheter displacement and infection), poor-quality fixation (may cause unplanned removal and skin injuries due to pressure), etc. causes more peripheral intravenous catheter fixation problems in pediatric patients than in adult patients Additional fixation products may be effective in preventing dislocation and micromotion in an active pediatric patient. However, limited recommendations regarding medical adhesive tapes and additional fixation products are guided only by low-evidence studies. The purpose of this study was to determine the effect of tubular bandage use on the duration of pediatric peripheral intravenous catheter use and the incidence of infiltration.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Start

First participant enrolled

February 10, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 27, 2024

Last Update Submit

August 28, 2024

Conditions

Keywords

child, infiltration,catheter usage time

Outcome Measures

Primary Outcomes (1)

  • pediatric peripheral infiltration scale, information collection form

    The effect of tubular bandage on infiltration and catheter use time in children will be analyzed.

    about a year

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group consisted of the group to which a tubular bandage was placed over the routinely applied peripheral intravenous catheters.

Combination Product: tubular bandage

control group

NO INTERVENTION

The routine practice used for the application of peripheral intravenous catheters in the ward constituted the control group.

Interventions

tubular bandageCOMBINATION_PRODUCT

The experimental group consisted of the group in which a tubular bandage was applied over the PIC, which was routinely applied.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Willingness to participate in the study
  • Parent/child's proficiency in Turkish
  • Intact skin integrity in the application area
  • First-time application of the peripheral venous catheter to the middle part of the child's forearm
  • Recommendation by a physician for intravenous fluid containing 5% dextrose, 0.45% NaCl, and 75% KCL through a peripheral venous catheter
  • Child's age between 6-12 years
  • Successful placement of the peripheral venous catheter on the first attempt

You may not qualify if:

  • Coagulation abnormalities
  • Receiving blood and blood products through the peripheral venous catheter
  • Nutritional issues
  • Hematologic or oncologic diseases
  • Congenital genetic or neurological disorders
  • Problems with skin integrity and movement in the upper extremities
  • Sensitivity to the tubular bandage
  • Fever above 37.5°C
  • Accidental dislodgement of the catheter
  • Early completion of treatment and removal of the catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

RECRUITING

Istanbul Unıversity

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (8)

  • Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, Mihala G, Chopra V, Rickard CM. Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021 Dec;124:104095. doi: 10.1016/j.ijnurstu.2021.104095. Epub 2021 Sep 26.

    PMID: 34689013BACKGROUND
  • Santos LMD, Conceicao TB, Silva CSGE, Tavares SS, Rocha PK, Avelar AFM. Care related to peripheral intravenous catheterism in pediatrics performed by nursing technicians. Rev Bras Enferm. 2021 Oct 18;75(2):e20200611. doi: 10.1590/0034-7167-2020-0611. eCollection 2021. English, Portuguese.

    PMID: 34669898BACKGROUND
  • Ullman AJ, Takashima M, Kleidon T, Ray-Barruel G, Alexandrou E, Rickard CM. Global Pediatric Peripheral Intravenous Catheter Practice and Performance: A Secondary Analysis of 4206 Catheters. J Pediatr Nurs. 2020 Jan-Feb;50:e18-e25. doi: 10.1016/j.pedn.2019.09.023. Epub 2019 Oct 21.

    PMID: 31648879BACKGROUND
  • Huang LS, Huang Y, Hu J. Current practices of peripheral intravenous catheter fixation in pediatric patients and factors influencing pediatric nurses' knowledge, attitude and practice concerning peripheral intravenous catheter fixation: a cross-sectional study. BMC Nurs. 2021 Nov 23;20(1):236. doi: 10.1186/s12912-021-00758-1.

    PMID: 34814906BACKGROUND
  • Corley A, Ullman AJ, Mihala G, Ray-Barruel G, Alexandrou E, Rickard CM. Peripheral intravenous catheter dressing and securement practice is associated with site complications and suboptimal dressing integrity: A secondary analysis of 40,637 catheters. Int J Nurs Stud. 2019 Dec;100:103409. doi: 10.1016/j.ijnurstu.2019.103409. Epub 2019 Aug 28.

    PMID: 31629208BACKGROUND
  • Corley A, Marsh N, Ullman AJ, Rickard CM. Peripheral intravenous catheter securement: An integrative review of contemporary literature around medical adhesive tapes and supplementary securement products. J Clin Nurs. 2023 May;32(9-10):1841-1857. doi: 10.1111/jocn.16237. Epub 2022 Feb 3.

    PMID: 35118759BACKGROUND
  • Bahl A, Gibson SM, Jankowski D, Chen NW. Short peripheral intravenous catheter securement with cyanoacrylate glue compared to conventional dressing: A randomized controlled trial. J Vasc Access. 2023 Jan;24(1):52-63. doi: 10.1177/11297298211024037. Epub 2021 Jun 11.

    PMID: 34112019BACKGROUND
  • Alexandrou E, Ray-Barruel G, Carr PJ, Frost SA, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM; OMG Study Group. Use of Short Peripheral Intravenous Catheters: Characteristics, Management, and Outcomes Worldwide. J Hosp Med. 2018 May 30;13(5). doi: 10.12788/jhm.3039.

    PMID: 29813140BACKGROUND

Study Officials

  • dilek sönmez sağlık

    dilek.sonmez@istanbul.edu.tr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 30, 2024

Study Start

February 10, 2024

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations