The journal of vascular access · 2025
The effects of a new device on mechanical complications of short peripheral intravenous catheters: A randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Blacker Christopher, Modiri Ali-Reza, Ljungman Gustaf, Frykholm Peter
Аннотация
BACKGROUND: Placement 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.
METHOD: This 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.
RESULTS: The 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% (p = 0.56), while the dislodgement rate was 3.4% versus 12% (p = 0.04) in the intervention and control group, respectively. For ITT, total mechanical complication rate was 42% versus 47% (p = 0.47) and the dislodgement rate was 4.2% versus 13% (p = 0.03) in the intervention and control groups. FASD implementation resulted in a 73% reduction in dislodgements in the PP, and a 68% reduction in the ITT analysis. No device related AEs were recorded.
CONCLUSION: The 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.
METHOD: This 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.
RESULTS: The 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% (p = 0.56), while the dislodgement rate was 3.4% versus 12% (p = 0.04) in the intervention and control group, respectively. For ITT, total mechanical complication rate was 42% versus 47% (p = 0.47) and the dislodgement rate was 4.2% versus 13% (p = 0.03) in the intervention and control groups. FASD implementation resulted in a 73% reduction in dislodgements in the PP, and a 68% reduction in the ITT analysis. No device related AEs were recorded.
CONCLUSION: The 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.