Prospective Observational Study of the Power PICC Family of Devices and Accessories

Becton, Dickinson and Company450 enrolled

Overview

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

Conditions

Peripherally Inserted Central Catheter

Interventions

Peripherally Inserted Central CatheterDEVICE

insertion of a Peripherally Inserted Central Catheter (PICC)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient, regardless of age or gender, for which the investigator has decided that one of the PowerPICC study devices for either short-or long-term venous access should be inserted as standard of care * Expected to be available for observation through the duration of PICC therapy (including outpatient therapy, if applicable) * Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.) Exclusion Criteria: * Presence of any device-related infection, bacteremia, or septicemia is known or suspected * Body size is insufficient to accommodate the size of implanted device * Known or suspected to be allergic to materials contained in the device * History of irradiation of prospective insertion site * Previous episode(s) of venous thrombosis or vascular surgical procedures at the prospective placement site * Local tissue factors which would prevent proper device stabilization and/or access

Locations (14)

Klinikum Klagenfurt

Klagenfurt, Austria

Medizinische Universität Wien

Vienna, Austria

University Hospitals KU Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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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