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

NCT03908866 | Unknown

• 1 other identifier: XJTU1AF2019LSK-2019-032
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboses, Venous; Infection; Economic Problems

Outcome Measures

Primary Outcomes (3)

• thrombotic complications

  radiographically-confirmed upper-extremity deep vein thrombosis

  up to 30 days or be discharged from hospital

• mechanical complications

  pneumothorax or hematoma caused by puncture

  up to 30 days or be discharged from hospital

• infectious complications

  catheter related bloodstream infection

  up to 30 days or be discharged from hospital

Secondary Outcomes (2)

• catheter replacement

  up to 30 days or be discharged from hospital

• cost effectiveness

  up to 30 days or be discharged from hospital

Study Arms (2)

PICC(Peripherally inserted central catheter)

EXPERIMENTAL

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

Other: PICC(Peripherally inserted central catheter)

CVC(Central venous catheter )

ACTIVE COMPARATOR

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

Other: CVC(Central venous catheter )

Interventions

PICC(Peripherally inserted central catheter) OTHER

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.

PICC(Peripherally inserted central catheter)

CVC(Central venous catheter ) OTHER

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.

CVC(Central venous catheter )

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Infections

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Hao Liu, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Liu, MD

CONTACT

0086-029-85324005; hao_liu@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 9, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

CN (1)