Study of Complication Rates Associated With PICC for Left vs Right

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01638702
First received: June 18, 2012
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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 Intervention
Bacterial Infections
Procedure: Placement of PICC in right arm
Procedure: PICC placement in Left arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Assessment of Impact of Choice of Arm for Access on Rate of Complications in Peripherally Inserted Central Venous Catheters

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

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


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Right sided PICC placement Procedure: Placement of PICC in right arm
Placement of PICC in right arm
Placebo Comparator: Left sided arm placement Procedure: PICC placement in Left arm
Placement of PICC in left arm

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638702

Contacts
Contact: Richard Lindsay, MB Bch BaO 514 9341934 ext 35666 rwklindsay@hotmail.com
Contact: France Paquet 514 9341934 ext 35666 france.paquet@muhc.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: France Paquet         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Richard Lindsay, MB Bch BaO McGill University Health Center
Principal Investigator: France Paquet McGill University Health Center
  More Information

No publications provided

Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT01638702     History of Changes
Other Study ID Numbers: 12-086-BMB
Study First Received: June 18, 2012
Last Updated: October 18, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on October 16, 2014