RecruitingNot ApplicableNCT06727240

Safe-Infusion Study

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

Sponsor

Interlinked AB

Enrollment

548 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Intravenous access MEDICAL DEVICE

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to <2h.
≥18 years of age
Speak and understand local language
VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion
Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent

Exclusion Criteria5

The VAD is expected to be used for sampling only
Pregnancy
Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
Patients under palliative care
Bolus IV infusion, defined as an infusion time of <15 min

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Interventions

DEVICEIntervention

The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.