Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.
Single-arm, post-market, observational, prospective study to asses the safety and performance of the Power PICC Power PICC family of devices and its accessories in a real-world setting. The study will only enroll patients that need a Power PICC catheter as part of their medical care. Patients will be followed from insertion through removal, or up to 180 days (whichever comes first). Data collected will be gathered from the patient's medical chart.
Study Type
OBSERVATIONAL
Enrollment
450
insertion of a Peripherally Inserted Central Catheter (PICC)
Klinikum Klagenfurt
Klagenfurt, Austria
Medizinische Universität Wien
Vienna, Austria
University Hospitals KU Leuven
Leuven, Belgium
Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access.
Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.
Time frame: from insertion though removal or 180 days, whichever comes first
Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period.
PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy.
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Phlebitis
Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Extravasation
Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Local Infection
Incidence of any new occurrence of local infection
Time frame: from insertion though removal or 180 days, whichever comes first
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fakultní nemocnice Olomouc
Olomouc, Czechia
Sygehus Soenderjylland, Sønderborg
Sønderborg, Denmark
Universitätsklinikum Jena
Jena, Germany
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, Italy
Ospedale Civile di Ivrea
Ivrea, Piedmont, Italy
A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette
Turin, Piedmont, Italy
Ospedale Centrale di Bolzano
Bolzano, Trentino-Alto Adige, Italy
...and 4 more locations
Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection
Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Catheter-related Bloodstream Infection.
Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a microorganism not related to another source (e.g., UTI) OR positive blood culture(s) with microorganism matching catheter tip culture OR blood cultures from peripheral venous puncture and PICC positive with the same microorganism.
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Accidental Dislodgement.
Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Vessel Laceration.
Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Vessel Perforation.
Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Performance: Percent of Patent Catheters
Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters.
Time frame: from insertion though removal or 180 days, whichever comes first
Secondary Performance: Percent of Placement Success in Single Insertion Attempt
Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter
Time frame: during the insertion procedure
Secondary Performance - Usability: Ease of Insertion
Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)
Time frame: during the insertion procedure