Catheterization, Peripheral
Conditions
Brief summary
This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.
Interventions
DEVICEPeripherally Inserted Central Venous Cather (PICC)
Location of the PICC insertion will be randomized and compared
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
Inclusion criteria
1. Neonates of all gestational ages admitted to Foothills Medical Centre and Alberta Children's Hospital Neonatal Intensive Care Unit (NICU) 2. Peripherally inserted central venous catheter (PICC) line insertion planned as part of NICU care 3. Venous access available in both upper(above umbilicus) and lower body
Exclusion criteria
1. Local infection at potential site of insertion 2. Hemangioma, lymphangioma or malformations in the region of insertion 3. Major chromosomal anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome is the presence of any complication which necessitates PICC removal | Through study completion, within 4 weeks | Line infiltration will be defined as extravasation of fluid into soft tissue around the region of the catheter tip. Line occlusion will be defined as inability to infuse fluid, resulting in removal of line. Phlebitis will be defined as presence of a linear red streak developing along the superficial veins from the catheter insertion site. Line associated thrombosis will be defined as ultrasound proven evidence of an occlusive thrombus in an anatomic location in proximity to the site of PICC.CLABSI will be defined according to Center for Disease Control definitions 26, that is, (1) confirmed primary bloodstream infection with (2) one of following clinical signs of infection (fever, hypothermia, apnea, or bradycardia) and (3) presence of central catheter at the time of or within 48 hours before the onset of the infection. Major life-threatening complications will include pleural effusion, pericardial effusion and cardiac tamponade, retroperitoneal extravasation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome will be time to complication post insertion | Through study completion, within 4 weeks | This will be defined as the interval between PICC line insertion and first detection of complication post insertion, expressed in days. |
Countries
Canada
Contacts
Primary ContactAmuchou Soraisham, MD
Outcome results
None listed