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
Recruitment status was Recruiting
Sponsor:
McGill University Health Center
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
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01638702
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 | |
| Montreal General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Royal Victoria Hospital | Recruiting |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Principal Investigator: France Paquet | |
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 February 27, 2015