Safe-Infusion Study
Recruiting now · Not applicable
Conditions studied: Intravenous Access, Medical Device
In brief
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.
Key facts
- Study ID
- NCT06727240
- Run by
- Interlinked AB
- People needed
- 548
- Starts
- 2024-03-25
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2024-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Centro Hospitalar e Universitário de Coimbra — Coimbra, Portugal (enrolling)
- Parc Sanitari Sant Joan de Déu — Barcelona, Spain
Full record on ClinicalTrials.gov
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