đź“Š Evidence-Based Reference
triple lumen right atrial catheter
Quinton
Summary: The triple lumen right atrial catheter by Quinton is used for hemodynamic monitoring and long-term venous access. Key evidence highlights its use in pediatric cardiac surgery and associated risks of thrombus formation.
FDA Clearance Information
Pathway
510K
Number
K852815 ↗
Decision Date
August 26, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The triple lumen right atrial catheter was cleared by the FDA via the 510k pathway on August 26, 1985. It is manufactured by Quinton and classified as a Class 2 device.
What It Is
The triple lumen right atrial catheter is a medical device designed for insertion into the right atrium of the heart. It is used primarily for hemodynamic monitoring and long-term venous access in clinical settings.
Clinical Applications
This device is commonly used in pediatric cardiac surgery for hemodynamic monitoring. It is also utilized for long-term venous access in patients requiring chemotherapy, intravenous fluids, or parenteral nutrition.
Evidence Summary
The literature includes 13 studies, comprising various study types such as RCTs, prospective, and retrospective studies, conducted between 2004 and 2020. These studies explore the device's efficacy and safety in clinical practice.
Reported Outcomes
Published studies report that the triple lumen right atrial catheter is effective for hemodynamic monitoring in pediatric cardiac surgery. It is also noted for its utility in providing long-term venous access, although specific efficacy metrics are not detailed in the available summaries.
Safety Profile
Reported complications include catheter-associated bloodstream infections and right atrial thrombus formation. These adverse events highlight the need for careful monitoring and management when using the device.
Evidence Limitations
The evidence base lacks comprehensive data on long-term outcomes and specific efficacy metrics. Further research is needed to better understand the risk factors for complications and to optimize device use in various clinical scenarios.
Frequently Asked Questions
What are the clinical indications for triple lumen right atrial catheter?
The device is indicated for hemodynamic monitoring and long-term venous access, particularly in pediatric cardiac surgery and patients requiring chemotherapy or parenteral nutrition.
What outcomes have been reported in clinical studies?
Studies report effective hemodynamic monitoring and long-term venous access, though specific efficacy metrics are not detailed in the summaries.
What complications have been reported?
Safety data indicate risks of catheter-associated bloodstream infections and right atrial thrombus formation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.