Study of Complication Rates Associated With PICC for Left vs Right

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Richard Lindsay, McGill University Health Center

ClinicalTrials.gov Identifier:

NCT01638702

First received: June 18, 2012

Last updated: March 14, 2016

Last verified: March 2016

History of Changes

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	Other: Follow up of complications


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

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.


Enrollment:	203
Study Start Date:	October 2012
Study Completion Date:	September 2015
Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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...)

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

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


Responsible Party:	Richard Lindsay, MD, 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:	March 14, 2016
Health Authority:	Canada: Health Canada
Individual Participant Data
Plan to Share IPD:	Undecided

Keywords provided by McGill University Health Center:


Catheterisation, Central Venous Catheters, Indwelling

Additional relevant MeSH terms:


Bacterial Infections

ClinicalTrials.gov processed this record on September 28, 2016

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