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.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants With at Least One PICC-Related Complication
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PICC: Efficacy and Safety
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .