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

Primary Purpose

Thromboses, Venous, Infection, Economic Problems

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PICC(Peripherally inserted central catheter)
CVC(Central venous catheter )
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thromboses, Venous

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PICC(Peripherally inserted central catheter)

CVC(Central venous catheter )

Arm Description

Patients randomly assigned to receive a peripherally inserted central catheter(PICC).

Patients randomly assigned to receive a centrally inserted central venous catheter(CVC).

Outcomes

Primary Outcome Measures

thrombotic complications
radiographically-confirmed upper-extremity deep vein thrombosis
mechanical complications
pneumothorax or hematoma caused by puncture
infectious complications
catheter related bloodstream infection

Secondary Outcome Measures

catheter replacement
obstruction or accidental removal
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.

Full Information

First Posted
April 7, 2019
Last Updated
April 21, 2019
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03908866
Brief Title
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit
Acronym
PICINI
Official Title
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboses, Venous, Infection, Economic Problems

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PICC(Peripherally inserted central catheter)
Arm Type
Experimental
Arm Description
Patients randomly assigned to receive a peripherally inserted central catheter(PICC).
Arm Title
CVC(Central venous catheter )
Arm Type
Active Comparator
Arm Description
Patients randomly assigned to receive a centrally inserted central venous catheter(CVC).
Intervention Type
Other
Intervention Name(s)
PICC(Peripherally inserted central catheter)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CVC(Central venous catheter )
Intervention Description
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.
Primary Outcome Measure Information:
Title
thrombotic complications
Description
radiographically-confirmed upper-extremity deep vein thrombosis
Time Frame
up to 30 days or be discharged from hospital
Title
mechanical complications
Description
pneumothorax or hematoma caused by puncture
Time Frame
up to 30 days or be discharged from hospital
Title
infectious complications
Description
catheter related bloodstream infection
Time Frame
up to 30 days or be discharged from hospital
Secondary Outcome Measure Information:
Title
catheter replacement
Description
obstruction or accidental removal
Time Frame
up to 30 days or be discharged from hospital
Title
cost effectiveness
Description
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.
Time Frame
up to 30 days or be discharged from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Liu, MD
Phone
0086-029-85324005
Email
hao_liu@xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Liu, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Liu, MD
Phone
0086-029-85324005
Email
hao_liu@xjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Hao Liu, MD
First Name & Middle Initial & Last Name & Degree
Wei Zhang

12. IPD Sharing Statement

Learn more about this trial

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

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