- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07834996
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Peripherally Inserted Central Venous Catheter: Efficacy and Safety
Central venous access is critical for administering intravenous medications, parenteral nutrition, and fluid therapy in intensive care units (ICUs). Peripherally inserted central catheters (PICCs) provide an alternative to traditional centrally placed catheters, but they can be associated with complications such as blood clots (thrombosis), catheter-related infections, and mechanical blockages. The primary purpose of this study is to assess the procedural efficacy, functional lifespan, and complication rates of ultrasound-guided PICCs in critically ill adult patients.
In this prospective observational study, 60 adult ICU patients who require central venous access for at least 5 to 7 days will undergo bedside PICC placement by radiology staff using real-time ultrasound guidance and the modified Seldinger technique. Proper positioning of the catheter tip will be verified by a portable chest radiograph immediately after insertion.
Participants will be monitored daily while the catheter remains in place until line removal, ICU discharge, or death. Surveillance includes daily clinical site inspections, structured laboratory assessments, and scheduled compression Doppler ultrasound scans to check for blood clots in the cannulated arm. If an infection or blockage is suspected, appropriate blood cultures and diagnostic work-ups will be conducted. The gathered data will determine the insertion success rate, functional patency rate, and the overall incidence of complications per 1,000 catheter-days to establish evidence-based guidelines for vascular access in critical care.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult critically ill patients aged 18 years or older admitted to the Intensive Care Unit (ICU) at Assiut University Hospital who require central venous access via a peripherally inserted central catheter (PICC) for clinical indications such as difficult peripheral venous access, administration of parenteral nutrition, prolonged intravenous antibiotic therapy (≥5 days), infusion of vesicant or vasoactive medications, or frequent blood sampling, with an anticipated need for central venous access or ICU stay of at least 5 to 7 days.
La description
Inclusion Criteria:
- Adult patients aged ≥ 18 years admitted to the Intensive Care Unit (ICU)
- Clinical requirement for central venous access via a peripherally inserted central catheter (PICC) (e.g., difficult peripheral venous access, parenteral nutrition, prolonged intravenous antibiotic therapy ≥ 5 days, or infusion of vesicant/vasoactive medications)
- Anticipated need for central venous access or ICU stay of at least 5 to 7 days
- Patient or legal representative willing and able to provide written informed consent
Exclusion Criteria:
- Age below 18 years
- Known hypersensitivity or allergy to catheter material (polyurethane or silicone)
- Local skin infection, cellulitis, or active thrombosis at the intended insertion site
- Documented ipsilateral upper-extremity or superior vena cava venous obstruction/stenosis precluding catheter passage
- Presence of an arteriovenous fistula or graft in the intended limb
- Severe, uncorrectable coagulopathy considered an absolute contraindication to catheter insertion
- Refusal of patient or legal guardian to provide informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Critically Ill Patients Receiving PICC
Adult patients (aged 18 years or older) admitted to the intensive care unit requiring central venous access for at least 5 to 7 days for indications such as difficult peripheral access, parenteral nutrition, prolonged intravenous antibiotic therapy, or vasoactive infusions. All enrolled participants undergo bedside ultrasound-guided peripherally inserted central catheter (PICC) placement performed by the Radiology Department using the modified Seldinger technique, with tip position confirmed by post-procedure chest radiograph. Patients are followed daily throughout the catheter dwell period until line removal, ICU discharge, or death to evaluate insertion success, functional patency, and procedural complications including catheter-related bloodstream infections, upper-extremity deep vein thrombosis, and mechanical failures. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With at Least One PICC-Related Complication
Délai: Up to 30 days
|
Number of patients who experience at least one PICC-related complication (including catheter occlusion, accidental dislodgement, catheter-related bloodstream infection confirmed per CDC/NHSN criteria, or catheter-related venous thrombosis confirmed by Doppler ultrasound) during the catheter dwell period. |
Up to 30 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Attributs de la maladie
- Infections
- Embolie et thrombose
- La thrombose veineuse
- Thrombose
- Conditions pathologiques, signes et symptômes
- Maladie critique
- Infections liées au cathéter
- Thrombose veineuse profonde des membres supérieurs
Autres numéros d'identification d'étude
- PICC: Efficacy and Safety
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