Intervention: The interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'. — Baseline PIVC data and immediatly after PIVC removal Mechanical complications are defied as following:
* Phlebitis -inflammation of a vein based on clinical diagnosis
* Infiltration - the process of accidental leakage of fluids out of the veins into peripheral tissue
* Occlusion - blocked PIVC, where flushing or aspirating from the PIVC is not possible
* Dislodgment - the process of accidental/ unintentional complete removal of the PIVC before scheduled removal
Trial sites (2)
Facility
City
Region
Status
Centro Hospitalar e Universitário de Coimbra
Coimbra
Portugal
Recruiting
Parc Sanitari Sant Joan de Déu
Barcelona
Spain
Completed
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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