Trial reportThe journal of vascular access2026
The effects of a new device on mechanical complications of short peripheral intravenous catheters: A randomized controlled trial.
Trial report in The journal of vascular access, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05814887 (Reduction of Mechanical IV Complication Using a New Medical Device), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Reduction of Mechanical IV Complication Using a New Medical Device
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPlacement of a short peripheral catheter (SPC) is one of the most common invasive procedures in healthcare. Catheter dysfunction occurs in up to 69%, caused by phlebitis, subcutaneous infiltration, occlusion, and dislodgement, conjointly considered as mechanical complications. Recent research has indicated that a new type of medical device, the force-activated separation device (FASD), may reduce these mechanical complications by 46%, but efficacy and safety data are lacking. The objective of this study was to investigate the efficacy and rate of adverse events (AEs) using a novel FASD.
methodThis was a single center randomized controlled trial comparing a FASD to standard of care, where primary outcome was rate of mechanical complications for each arm. Adult patients, admitted to either a stroke ward or orthopedic ward at a University Hospital were eligible.
resultsThe population was mainly male, elderly, and had multiple co-morbidities. The study included 146 patients, contributing with a total of 194 catheters for the per protocol (PP) and 203 for the intention to treat (ITT) analyses. In the PP analysis, the total mechanical complication rate was 42% versus 46% (
conclusionThe implementation of a novel FASD did not demonstrate a reduction of total mechanical complications, however, a 73% reduction in dislodgements in the PP, and a 68% reduction in the ITT analysis was noted. No device-related AEs were recorded.Clinical Trials; clinicaltrials.gov; ID: NCT05814887.
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