Reduction of Mechanical IV Complication Using a New Medical Device (NCT05814887) | Clinical Trial Compass
CompletedNot Applicable
Reduction of Mechanical IV Complication Using a New Medical Device
Sweden200 participantsStarted 2023-05-04
Plain-language summary
Peripheral intravenous catheters are necessary for in-hospital medical treatment. Malfunction due to occlusion or dislodgement is common, and increases the burden on health care.
The aim of this study is to determine if the use of a new medical device has an impact on mechanical complications rate when peripheral intravenous (IV) catheter is used. The study will also investigate the safety, opinions of healthcare personnel and health economic effects of this new device,
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient has or will get a PIVC expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥ 2h and intermittent as an infusion lasting 15min to \< 2h.
* ≥18 years of age
* Speaks and understands Swedish
Exclusion Criteria:
* The PIVC is expected to be used for sampling only
* Pregnancy
* Unable to obtain informed consent or without an available Next-of-kin to provide surrogate informed consent
* Patients under palliative care
* Bolus IV infusion, defined as an infusion time of \<15 min
* Phlebitis, infiltration or occlusion associated with PIVC that is already in place at the time of inclusion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of mechanical complications of an IV therapy session using a new medical device (ReLink) compared to using current 'state of the art'.