Safe-Infusion Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInterlinked AB
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intervention
Treatment groups
548 Participants
are divided into 2 treatment groupsSponsors and collaborators
Interlinked AB
Lead sponsor
Parc Sanitari Sant Joan de Déu
Collaborator
Unidade Local de Saúde de Coimbra, EPE
Collaborator
Source ClinicalTrials.gov