title: Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.
abstract: BACKGROUND
  The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard).
  
  
  METHODS
  In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability.
  
  
  RESULTS
  15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p < 0.0001). The blood control device had a lower incidence of blood leakage (14.1% vs 68.4%), was superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p < 0.0001).
  
  
  CONCLUSIONS
  In comparison with the hospital-standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process.
authors.affiliation: Smiths Medical, ASD, Inc., 1265 Grey Fox Road, St. Paul, MN 55112, USA.
authors.forename: Laura E
authors.initials: LE
authors.lastname: Seiberlich
authors.affiliation: Department of Emergency Medicine, Foothills Medical Centre, 1403 29 Street NW, Calgary, Alberta, Canada T2N 2T9.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Keay
authors.affiliation: Department of Emergency Medicine, University of Calgary and Alberta Health Services, 1403 29 Street NW, Calgary, Alberta, Canada T2N 2T9.
authors.forename: Stephane
authors.initials: S
authors.lastname: Kallos
authors.affiliation: Department of Emergency Medicine, University of Calgary and Alberta Health Services, 1403 29 Street NW, Calgary, Alberta, Canada T2N 2T9.
authors.forename: Tiffany
authors.initials: T
authors.lastname: Junghans
authors.affiliation: Department of Emergency Medicine, University of Calgary and Alberta Health Services, 1403 29 Street NW, Calgary, Alberta, Canada T2N 2T9.
authors.forename: Eddy
authors.initials: E
authors.lastname: Lang
authors.affiliation: Department of Emergency Medicine, University of Calgary and Alberta Health Services, 1403 29 Street NW, Calgary, Alberta, Canada T2N 2T9. Electronic address: amcrae@ucalgary.ca.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: McRae
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002406:Catheterization, Peripheral / Q000379:methods*; D002408:Catheters, Indwelling / Q000592:standards*; D005260:Female; D006801:Humans; D017758:Infectious Disease Transmission, Patient-to-Professional / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009726:Nurses / Q000592:standards; D011446:Prospective Studies
keywords: Blood control; Blood exposure; Closed system; Emergency nursing; Mucocutaneous exposure; Needlestick injury reduction; Peripheral intravenous catheters; Safety valved catheter