- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07649499
The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-related Infiltration and Phlebitis in the Pediatric Emergency Department
The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-Related Infiltration and Phlebitis in the Pediatric Emergency Department: A Quasi-Experimental Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye)
- Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Children admitted to the Pediatric Emergency Department
First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years
At least 6 hours of observation after catheter insertion
Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium)
Written informed consent obtained from parents/legal guardians
Children willing to participate in the study
Exclusion Criteria:
Children with skin problems (e.g., epidermolysis bullosa)
Children allergic to products used in the care bundle
Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies)
Children transferred to intensive care or another department after PIVC insertion
Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group (Care Bundle)
The intervention group will receive a care bundle consisting of the following: Nurse Education on peripheral intravenous catheter (PIVC) management. Hand Hygiene and adherence to aseptic techniques during PIVC insertion. Use of 2% chlorhexidine and 70% alcohol antiseptic solutions for PIVC insertion. Hydrocolloid transparent adhesive bandage for stabilization of the catheter. Nurses will avoid performing more than two attempts for PIVC insertion. Aseptic technique will be strictly followed during PIVC insertion and maintenance. |
The intervention group will receive a care bundle designed to reduce peripheral intravenous catheter (PIVC)-related complications (infiltration and phlebitis). The bundle includes the following components: Nurse Education: Training on PIVC management and best practices. Hand Hygiene: Emphasis on proper hand hygiene before and after each insertion and maintenance procedure. Aseptic Techniques: Strict adherence to aseptic technique during PIVC insertion and maintenance. Antiseptic Solutions: Use of 2% chlorhexidine and 70% alcohol for skin preparation and catheter insertion. Stabilization: Use of hydrocolloid transparent adhesive bandages for catheter fixation to prevent dislodgement and reduce irritation. Insertion Attempts: Limiting the number of attempts to a maximum of two to reduce trauma to the insertion site. Monitoring and Documentation: Regular assessment of the PIVC site for complications and accurate documentation by nursing staff. |
|
Ingen indgriben: Control Group (Standard Care)
The control group will receive standard care as per routine practice in the pediatric emergency department: Standard peripheral intravenous catheter (PIVC) insertion procedures as performed by clinical staff. No additional interventions such as nurse education or the specific antiseptic solutions or stabilization methods will be applied. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Peripheral Intravenous Catheter-Related Infiltration
Tidsramme: From the time of catheter insertion to 6 hours post-insertion
|
The primary outcome is the incidence of PIVC-related infiltration in pediatric patients.
Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
|
From the time of catheter insertion to 6 hours post-insertion
|
|
Incidence of Peripheral Intravenous Catheter-Related Phlebitis
Tidsramme: From the time of catheter insertion to 6 hours post-insertion.
|
the incidence of PIVC-related phlebitis.
Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).
|
From the time of catheter insertion to 6 hours post-insertion.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
First Attempt Success Rate for PIVC Insertion
Tidsramme: Procedure (During initial PIVC insertion attempt.)
|
The percentage of successful PIVC insertions on the first attempt.
|
Procedure (During initial PIVC insertion attempt.)
|
|
Number of PIVC Insertions
Tidsramme: At the time of PIVC insertion procedure
|
The total number of PIVC insertion attempts for each patient. Assessment Method: Clinical record review. |
At the time of PIVC insertion procedure
|
|
Nurse Adherence to Care Bundle Protocol
Tidsramme: At the time of PIVC insertion procedure
|
The degree to which nurses adhere to the care bundle protocol (hand hygiene, aseptic techniques, antiseptic use, etc.). Assessment Method: Adherence checklists and observation by researchers |
At the time of PIVC insertion procedure
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GizemPIVC2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Phlebitis
-
University of BasrahUniversity of BaghdadIkke rekrutterer endnuKræft | Kemoterapi
-
Federal University of São PauloAfsluttet
-
Kahramanmaras Sutcu Imam UniversityAfsluttet
-
Royal Brisbane and Women's HospitalUkendt
-
Hospital Universitario Marqués de ValdecillaRekruttering
-
Komar University of Science and TechnologyUkendt
-
The Reading Hospital and Medical CenterAfsluttetPhlebitis | Infiltration | Kateterisering, perifer venøsForenede Stater