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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intervention
DeviceThe interventional device is a coupling device intended to prevent mechanical complications during peripheral intravenous infusions. While control will not receive the device.
Treatment groups
548 Participants
are divided into 2 treatment groupsGroup A: ReLink®Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The rate of mechanical complications of an IV therapy session using the device compared to using current 'state of the art'.
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
Time frame
Baseline PIVC data and immediatly after PIVC removalSecondary outcomes
1
Frequency and severity of any adverse events
Time frame
Through study participation (hospitlized in the ward), an average of 5 days2
Healthcare workers opinion of investigational device
A questionnaire has been developed asking baseline data from healthcare worker. The questionnaire contains questions about 1) opinion about using the device again, 2) recommendation of the device, and 3) usage of the device for a relative. Each question is ranked from 0 to 5.
Time frame
Immediately after the intervention3
The economic cost of these disruptions to your facility in terms of man-hours, and resources.
Time frame
Immediatly after PIVC removalSponsors and contacts
Click on the lead sponsor to view all of their trials.
Interlinked AB
Lead sponsor
Parc Sanitari Sant Joan de Déu
Collaborator
Unidade Local de Saúde de Coimbra, EPE
Collaborator
Source ClinicalTrials.gov