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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03908866

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

22.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thromboses, Venous Infection Economic Problems	Other: PICC(Peripherally inserted central catheter) Other: CVC(Central venous catheter )	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PICC(Peripherally inserted central catheter) Patients randomly assigned to receive a peripherally inserted central catheter(PICC).	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.
Active Comparator: CVC(Central venous catheter ) Patients randomly assigned to receive a centrally inserted central venous catheter(CVC).	Other: 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.

Arm

Intervention/Treatment

Experimental: PICC(Peripherally inserted central catheter)

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

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.

Active Comparator: CVC(Central venous catheter )

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

Other: 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.

Outcome Measures

Primary Outcome Measures

thrombotic complications [up to 30 days or be discharged from hospital]
radiographically-confirmed upper-extremity deep vein thrombosis
mechanical complications [up to 30 days or be discharged from hospital]
pneumothorax or hematoma caused by puncture
infectious complications [up to 30 days or be discharged from hospital]
catheter related bloodstream infection

Secondary Outcome Measures

catheter replacement [up to 30 days or be discharged from hospital]
obstruction or accidental removal
cost effectiveness [up to 30 days or be discharged from hospital]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

Principal Investigator: Hao Liu, MD, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT03908866

Other Study ID Numbers:

XJTU1AF2019LSK-2019-032

First Posted:

Apr 9, 2019

Last Update Posted:

Apr 23, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombosis

Venous Thrombosis

Study Results

No Results Posted as of Apr 23, 2019