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临床试验/NCT07834996
NCT07834996尚未招募不适用

Peripherally Inserted Central Venous Catheter: Efficacy and Safety

Assiut University0 个研究点目标入组 60 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Number of Participants With at Least One PICC-Related Complication

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

Number of Participants With at Least One PICC-Related Complication

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ashraf Mohamed Falah

Resident of Radiology

Assiut University

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