Study of Complication Rates Associated With PICC for Left vs Right
Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters
1 other identifier
interventional
203
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 16, 2016
March 1, 2016
2.9 years
June 18, 2012
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Effect of number of lumens
From insertion to time of removal, an estimated average time of four weeks.
Study Arms (2)
Right sided PICC placement
ACTIVE COMPARATORInsertion of PICC on the right arm
Left sided arm placement
PLACEBO COMPARATORInsertion of PICC on the left arm
Interventions
Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)
Eligibility Criteria
You may qualify if:
- Referral for in-patient PICC placement at centre carrying out study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Richard Lindsaylead
Study Sites (2)
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lindsay, MB Bch BaO
McGill University Health Centre/Research Institute of the McGill University Health Centre
- PRINCIPAL INVESTIGATOR
France Paquet, BS(N) MS(N)
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 18, 2012
First Posted
July 12, 2012
Study Start
October 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 16, 2016
Record last verified: 2016-03