Assessing a new device to reduce complications from intravenous catheters
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
This study is testing a new device to see if it can help reduce problems caused by IV catheters in hospitalized patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 548 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Interlinked AB Industry-sponsored |
| Locations | 2 sites (Coimbra and 1 other locations) |
| Trial ID | NCT06727240 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require a vascular access device for continuous or intermittent IV infusion therapy.
Not a fit: Patients who are pregnant, under palliative care, or those requiring a vascular access device solely for sampling will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of complications associated with intravenous access, improving patient comfort and outcomes.
How similar studies have performed: Previous studies have indicated that addressing mechanical irritation may reduce PIVC failure rates, suggesting that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Coimbra and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.