Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit

Infection Clinical Trial

— PICINI  

Official title:

Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908866
• Other study ID #: XJTU1AF2019LSK-2019-032
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Hao Liu, MD
• Phone: 0086-029-85324005
• Email: hao_liu[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.

Exclusion Criteria:

• Insertion of the central catheter in emergency situations;

• Anatomical abnormalities of upper extremity affecting PICC placement;

• Current or recent (within 1 month) diagnosis of bacteremia

• Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;

• Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;

Related Conditions & MeSH terms

• Economic Problems
• Infection
• Thromboses, Venous
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• PICC(Peripherally inserted central catheter)
The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.
• CVC(Central venous catheter )
The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombotic complications	radiographically-confirmed upper-extremity deep vein thrombosis	up to 30 days or be discharged from hospital
Primary	mechanical complications	pneumothorax or hematoma caused by puncture	up to 30 days or be discharged from hospital
Primary	infectious complications	catheter related bloodstream infection	up to 30 days or be discharged from hospital
Secondary	catheter replacement	obstruction or accidental removal	up to 30 days or be discharged from hospital
Secondary	cost effectiveness	The cost of catheter implantation and replacement, as well as the cost of treatment due to catheter-related complications and the resulting financial loss to the patient.	up to 30 days or be discharged from hospital