Back to resultsStudy of Complication Rates Associated With PICC for Left vs Right
Primary Purpose
Bacterial Infections
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Follow up of complications
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Infections focused on measuring Catheterisation, Central Venous, Catheters, Indwelling
Eligibility Criteria
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.
Sites / Locations
- Montreal General Hospital
- Royal Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Right sided PICC placement
Left sided arm placement
Arm Description
Insertion of PICC on the right arm
Insertion of PICC on the left arm
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effect of number of lumens
Assessing the effect number of lumens in the catheter has on complication rate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01638702
Brief Title
Study of Complication Rates Associated With PICC for Left vs Right
Official Title
Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Lindsay
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Catheterisation, Central Venous, Catheters, Indwelling
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right sided PICC placement
Arm Type
Active Comparator
Arm Description
Insertion of PICC on the right arm
Arm Title
Left sided arm placement
Arm Type
Placebo Comparator
Arm Description
Insertion of PICC on the left arm
Intervention Type
Other
Intervention Name(s)
Follow up of complications
Intervention Description
Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)
Primary Outcome Measure Information:
Title
Line infection rate
Description
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.
Time Frame
From insertion to line removal, an estimated time of 4 weeks
Secondary Outcome Measure Information:
Title
Effect of number of lumens
Description
Assessing the effect number of lumens in the catheter has on complication rate.
Time Frame
From insertion to time of removal, an estimated average time of four weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lindsay, MB Bch BaO
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
France Paquet, BS(N) MS(N)
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Complication Rates Associated With PICC for Left vs Right
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