ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Complication Rates Associated With PICC for Left vs Right

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01638702
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Richard Lindsay, McGill University Health Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Other: Follow up of complications Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters
Study Start Date : October 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Right sided PICC placement
Insertion of PICC on the right arm
 Other: Follow up of complications
Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)
Placebo Comparator: Left sided arm placement
Insertion of PICC on the left arm
 Other: Follow up of complications
Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Line infection rate [ Time Frame: From insertion to line removal, an estimated time of 4 weeks ]
    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 :
  1. Effect of number of lumens [ Time Frame: From insertion to time of removal, an estimated average time of four weeks. ]
    Assessing the effect number of lumens in the catheter has on complication rate.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638702


Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
Richard Lindsay
Investigators
Principal Investigator: Richard Lindsay, MB Bch BaO McGill University Health Center
Principal Investigator: France Paquet, BS(N) MS(N) McGill University Health Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Richard Lindsay, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01638702     History of Changes
Other Study ID Numbers: 12-086-BMB
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Richard Lindsay, McGill University Health Center:
Catheterisation, Central Venous
Catheters, Indwelling

Additional relevant MeSH terms:
Bacterial Infections