Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365528
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-10
Brief Title:
Tunneled Peripherally Inserted Central Catheter PICC in Adult Patients and Associated Outcomes
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Tunneled Versus Non-Tunneled Peripherally Inserted Central Catheter and Their Effects on Reducing Combined or Isolated Outcomes Obstruction Infection Thrombosis and Dislodgement Multicenter Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection thrombosis obstruction and accidental dislodgement in the adult population within a period of up to 30 days
Detailed Description:
The data published this year from a multicenter study in Brazil presenting the patterns of use and clinical outcomes of PICC indicated that centers with vascular access teams adoption of best practices and current technologies result in low rates of complications such as primary bloodstream infections related to the catheter deep vein thrombosis and reversible occlusion Despite these more recent data showing that complications related to PICC can be mitigated by the use of technology vascular access teams adoption of best practices and infection control measures there is still room to incorporate new techniques in PICC insertion with the aim of further reducing avoidable complications For example recent studies with robust methodology have demonstrated the benefit of the tunneling technique compared to the conventional insertion technique A randomized clinical trial showed that the dwell time of the device inserted using the tunneling technique was longer compared to the conventional technique without tunneling in adult patients along with a lower incidence of thrombosis and infection At the Hospital de Clínicas de Porto Alegre recently nurses from the PICC Team were trained in the tunneling technique at a reference center in Brazil The initial results of tunneling in adult pediatric and neonatal patients are encouraging
The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams adoption of best practices related to catheter care and active ongoing education To our knowledge robust studies of this nature are not currently being conducted in Brazil
The observed results of implementing the technique indicate that there is potential to reduce avoidable complications and prompt us to propose a multicenter randomized controlled trial involving two additional institutions with similar profiles regarding the composition of Vascular Access Teams adoption of best practices related to catheter care and active ongoing education To our knowledge robust studies of this nature are not currently being conducted in Brazil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None