- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
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Aucune intervention: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Peripheral Intravenous Catheter-Related Infiltration
Délai: From the time of catheter insertion to 6 hours post-insertion
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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).
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From the time of catheter insertion to 6 hours post-insertion
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Incidence of Peripheral Intravenous Catheter-Related Phlebitis
Délai: From the time of catheter insertion to 6 hours post-insertion.
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the incidence of PIVC-related phlebitis.
Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).
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From the time of catheter insertion to 6 hours post-insertion.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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First Attempt Success Rate for PIVC Insertion
Délai: Procedure (During initial PIVC insertion attempt.)
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The percentage of successful PIVC insertions on the first attempt.
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Procedure (During initial PIVC insertion attempt.)
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Number of PIVC Insertions
Délai: At the time of PIVC insertion procedure
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The total number of PIVC insertion attempts for each patient. Assessment Method: Clinical record review. |
At the time of PIVC insertion procedure
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Nurse Adherence to Care Bundle Protocol
Délai: At the time of PIVC insertion procedure
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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
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GizemPIVC2025
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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