Study of Complication Rates Associated With PICC for Left vs Right

Bacterial Infections Clinical Trial

Official title:

Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638702
• Other study ID #: 12-086-BMB
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: March 14, 2016
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Peripherally inserted central catheter (PICC) are catheters that are placed mainly in the arms, but which pass in the veins to beside the heart. They are associated with occasional complications due to infection or blockage of the vein that they are in. The investigators want to investigate whether PICCs in the right arm have lower complications than those in the left. This difference in complication rates has been noticed in most other forms of central venous access.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Referral for in-patient PICC placement at centre carrying out study.

Exclusion Criteria:

• Out of hospital referrals for PICC placement; previous PICC placement; previous long term central catheter/pacemaker; unable to give valid consent; presence of pre-existing medical preventing randomisation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Other:
• Follow up of complications
Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Richard Lindsay

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Line infection rate	All patients will be followed from the point of time of randomisation and PICC insertion until the line develops a complication or is removed. The average length of duration of line access in our institution is 4 weeks.	From insertion to line removal, an estimated time of 4 weeks	Yes
Secondary	Effect of number of lumens	Assessing the effect number of lumens in the catheter has on complication rate.	From insertion to time of removal, an estimated average time of four weeks.	Yes