Catheterization, Peripheral Clinical Trial
Official title:
Peripherally Inserted Central Venous Catheter Insertion Site and Complication Rates in Neonates
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.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome is the presence of any complication which necessitates PICC removal | 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. | Through study completion, within 4 weeks | |
Secondary | Secondary outcome will be time to complication post insertion | This will be defined as the interval between PICC line insertion and first detection of complication post insertion, expressed in days. | Through study completion, within 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05299060 -
Effectiveness of Cyanoacrylate Glue in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial (CIANO-ETI)
|
N/A | |
Terminated |
NCT00482742 -
Safety & Performance Randomized Study of the CiTop™ Guidewire for Peripheral CTO
|
N/A | |
Completed |
NCT00357799 -
VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access
|
Phase 2/Phase 3 | |
Completed |
NCT03563703 -
Transfer of Technological Innovations to Nursing Practice: A Contribution to the Prevention of Infections
|
N/A | |
Completed |
NCT05265481 -
The Effect of Tapping in the Venous Dilatation for Peripheral IV Access
|
N/A | |
Active, not recruiting |
NCT02648334 -
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease
|
N/A | |
Completed |
NCT03148808 -
Natural Vascular Scaffold (NVS) Therapy
|
Phase 1 | |
Completed |
NCT04188262 -
Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)
|
Phase 1 | |
Completed |
NCT04085042 -
Impact of a Multimodal Intervention on Peripheral Venous Catheterization of Cancer Patients
|
N/A | |
Recruiting |
NCT04856826 -
Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service
|
N/A | |
Terminated |
NCT01104103 -
Effectiveness Study of the BOA(R)-Constricting IV Band
|
N/A | |
Completed |
NCT00665886 -
Compact Closed System Versus Mounted Open System (COSMOS)
|
Phase 4 | |
Completed |
NCT02795468 -
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
|
N/A | |
Completed |
NCT02769442 -
Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED
|
N/A | |
Recruiting |
NCT03592602 -
Evaluate the Impact of Arm Abduction and Adduction on the Intravascular Electrocardiograph During PICC Placement and the Tip Location Changes Related to it
|
N/A | |
Completed |
NCT04001764 -
Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
|
N/A | |
Completed |
NCT03197246 -
Intravascular ECG During Insertion of Peripheral Inserted Central-venous Catheters: Replacement for Chest X-ray?
|
N/A | |
Terminated |
NCT05051020 -
Near-infrared Vein Imaging for Peripheral IV Placement
|
N/A | |
Terminated |
NCT04262947 -
Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement
|
N/A | |
Completed |
NCT06033677 -
Increasing Security With End-zone Arterial Blood Pressure Monitoring During Surgery
|
N/A |