Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services

NCT06312215 | Completed

• 1 other identifier: 1763831
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted as a randomized controlled experimental research to examine the effects of open and closed system peripheral catheters on the success of insertion, duration of stay, and development of complications in children aged 1-18 years in pediatric services. The population of the study consisted of children admitted to the Pediatric Services of the Istanbul Faculty of Medicine, and the sample included a total of N=80 children who met the sample criteria and underwent catheter insertion between May 2023 and October 2023. The sample was divided into two groups: closed system peripheral venous catheter group (n=40) and open system peripheral venous catheter group (n=40). The data of the study were collected using a Data Collection Form, Peripheral Venous Catheter Monitoring Form, Visual Infusion Phlebitis Detection Scale, and Pediatric Peripheral Intravenous Infiltration Scale

Conditions

Child, Only; Catheter Infection; Catheter Complications

Keywords

Closed System Peripheral Catheter; Peripheral Catheter; child

Outcome Measures

Primary Outcomes (4)

• Patient Identification Form

  he Patient Identification Form has been prepared by reviewing relevant literature. It consists of 27 questions, encompassing patient-specific information and catheter characteristics.

  1 day

• Daily Monitoring Form

  his form, comprised of 8 questions, has been designed to monitor patients on a daily basis, covering aspects such as catheter day, fluids administered, phlebitis score, infiltration score, skin characteristics, and signs of infection. Nurses used the Daily Monitoring Form to observe and record patient conditions on a daily basis.

  1 day

• Visual Infusion Phlebitis Assessment Scale, Staging Key - Peripheral IV'sVIPAS

  Developed by Alyce Schultze and Paulette Gallant, this scale was published by the Infusion Nurses Society in 2011 for the purpose of grading phlebitis. The scale involves observing the possible risks of the catheter during the administration of treatment through a peripheral intravenous catheter. It also includes grading the symptoms of phlebitis at each stage if phlebitis develops. The content validity index value of the scale was found to be 0.97

  1 day

• Pediatric peripheral intravenous infiltration assessment tool

  Pediatric peripheral intravenous infiltration assessment tool: Developed by Simona and evaluated for its psychometric properties, the Pediatric Peripheral Intravenous Infiltration Scale has undergone Turkish validity and reliability assessments by Temizsoy et al. (2017) and is suitable for use in newborns. Cohen kappa value of the scale was 0.80 (p\<0.001) and Pearson correlation coefficient was r=0.95 (p\<0.001). The Cronbach's alpha coefficient of the scale is 0.966, which shows that the level of infitration increases as the stages increase in the evaluation made in five stages.

  1 day

Study Arms (2)

Closed System Peripheral Catheters

EXPERIMENTAL

After the area where the catheter would be inserted was cleaned with an antiseptic solution and allowed to dry, a closed-system catheter was applied. Closed-system catheters are devices that allow access through needleless mechanisms, protecting the patient from accidental needle puncture injuries. They have mechanisms preventing blood leakage or pathogen entry.

Other: Closed-system catheter

Control

NO INTERVENTION

After the area where the catheter would be inserted was cleaned with an antiseptic solution and allowed to dry, a catheter was applied.

Interventions

Closed-system catheter OTHER

Closed-system catheters was applied

Closed System Peripheral Catheters

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being between 1 and 18 years of age,
• Having a catheter requirement for at least 72 hours,
• The catheter being inserted in the admitting service,
• Catheters not being inserted under emergency conditions,
• Absence of other catheters (central venous, arterial, PICC line, etc.),
• Body temperature not exceeding 38°C,
• Absence of skin issues in the catheter area,
• Not undergoing chemotherapy treatment,
• The catheter being inserted in the upper extremity,
• Willingness to voluntarily participate in the study.

You may not qualify if:

• Being under 1 year of age or over 18 years,
• Having a catheter requirement of less than 72 hours,
• Peripheral catheters being inserted under emergency conditions,
• Presence of other catheters in the child (central venous, arterial, PICC line, etc.),
• Body temperature exceeding 38°C,
• Presence of skin issues in the area where the catheter will be inserted,
• Undergoing chemotherapy treatment,
• Unwillingness to voluntarily participate in the study.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (8)

• Amjad I, Murphy T, Nylander-Housholder L, Ranft A. A new approach to management of intravenous infiltration in pediatric patients: pathophysiology, classification, and treatment. J Infus Nurs. 2011 Jul-Aug;34(4):242-9. doi: 10.1097/NAN.0b013e31821da1b3.

  PMID: 21734520 BACKGROUND

• Clark E, Giambra BK, Hingl J, Doellman D, Tofani B, Johnson N. Reducing risk of harm from extravasation: a 3-tiered evidence-based list of pediatric peripheral intravenous infusates. J Infus Nurs. 2013 Jan-Feb;36(1):37-45. doi: 10.1097/NAN.0b013e3182798844.

  PMID: 23271150 BACKGROUND

• 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: 31629208 BACKGROUND

• Doellman D, Hadaway L, Bowe-Geddes LA, Franklin M, LeDonne J, Papke-O'Donnell L, Pettit J, Schulmeister L, Stranz M. Infiltration and extravasation: update on prevention and management. J Infus Nurs. 2009 Jul-Aug;32(4):203-11. doi: 10.1097/NAN.0b013e3181aac042.

  PMID: 19605999 BACKGROUND

• Duncan M, Warden P, Bernatchez SF, Morse D, (2018), A bundled approach to decrease the rate of primary bloodstream infections related to peripheral intravenous catheters, J Assoc Vasc Access, 23(1), 15-22.

  BACKGROUND

• Arias-Fernandez L, Suerez-Mier B, Martinez-Ortega MD, Lana A. Incidence and risk factors of phlebitis associated to peripheral intravenous catheters. Enferm Clin. 2017 Mar-Apr;27(2):79-86. doi: 10.1016/j.enfcli.2016.07.008. Epub 2016 Sep 16. English, Spanish.

  PMID: 27640931 BACKGROUND

• Gonzalez Lopez JL, Arribi Vilela A, Fernandez del Palacio E, Olivares Corral J, Benedicto Marti C, Herrera Portal P. Indwell times, complications and costs of open vs closed safety peripheral intravenous catheters: a randomized study. J Hosp Infect. 2014 Feb;86(2):117-26. doi: 10.1016/j.jhin.2013.10.008. Epub 2013 Dec 1.

  PMID: 24373830 BACKGROUND

• Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.

  PMID: 33394637 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: May 26, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

TU (1)