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Summary
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.
Official title: A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
548
Start Date
2024-03-25
Completion Date
2025-03
Last Updated
2024-12-16
Healthy Volunteers
No
Conditions
Interventions
Intervention
The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.
Locations (2)
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal
Parc Sanitari Sant Joan de Déu
Barcelona, Spain