Assessing a new device to reduce complications from intravenous catheters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a new medical device designed to minimize mechanical complications associated with peripheral intravenous catheters (PIVCs), which are commonly used in hospitalized patients. It will involve a non-inferiority randomized trial across two sites, recruiting a total of 548 patients. The primary focus will be on measuring complication rates, while secondary outcomes will include adverse events, healthcare feedback, and economic impacts related to the use of the device. The study aims to address the high failure rates of PIVCs, which can lead to significant patient discomfort and healthcare costs.

Why it matters

Who can join: the full rules

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

Where it's running

• Centro Hospitalar e Universitário de Coimbra
  Coimbra, Portugal Recruiting
• Parc Sanitari Sant Joan de Déu
  Barcelona, Spain Completed

Study contacts

• Principal investigator: Ramon Mir Abellán, PhD — Parc Sanitari Sant Joan de Déu
• Study coordinator: Christopher Blacker, Medical Doctor
• Email: christopher.blacker@uu.com
• Phone: +46737301399

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.