Prospective Observational Study of the Power PICC Family of Devices and Accessories
- Conditions
- Peripherally Inserted Central Catheter
- Interventions
- Device: Peripherally Inserted Central Catheter
- Registration Number
- NCT04263649
- Lead Sponsor
- Becton, Dickinson and Company
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- 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.)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All subjects Peripherally Inserted Central Catheter patients who require a PICC
- Primary Outcome Measures
Name Time Method 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. from insertion though removal or 180 days, whichever comes first Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.
Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period. from insertion though removal or 180 days, whichever comes first 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.
- Secondary Outcome Measures
Name Time Method Secondary Safety: Incidence of Catheter-related Bloodstream Infection. from insertion though removal or 180 days, whichever comes first 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.
Secondary Safety: Incidence of Accidental Dislodgement. from insertion though removal or 180 days, whichever comes first Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.
Secondary Safety: Incidence of Vessel Laceration. from insertion though removal or 180 days, whichever comes first Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.
Secondary Safety: Incidence of Phlebitis from insertion though removal or 180 days, whichever comes first Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation
Secondary Safety: Incidence of Local Infection from insertion though removal or 180 days, whichever comes first Incidence of any new occurrence of local infection
Secondary Performance: Percent of Patent Catheters from insertion though removal or 180 days, whichever comes first Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters.
Secondary Performance - Usability: Ease of Insertion during the insertion procedure Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)
Secondary Safety: Incidence of Extravasation from insertion though removal or 180 days, whichever comes first Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter
Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection from insertion though removal or 180 days, whichever comes first Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection
Secondary Safety: Incidence of Vessel Perforation. from insertion though removal or 180 days, whichever comes first Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.
Secondary Performance: Percent of Placement Success in Single Insertion Attempt during the insertion procedure Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter
Trial Locations
- Locations (14)
Fakultní nemocnice Olomouc
🇨🇿Olomouc, Czechia
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Piedmont, Italy
HAGA Ziekenhuis
🇳🇱Den Haag, Netherlands
A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette
🇮🇹Turin, Piedmont, Italy
Institut für Diagnostische und Interventionelle Radiologie
🇨🇭Zürich, Switzerland
Medizinische Universität Wien
🇦🇹Vienna, Austria
University Hospitals KU Leuven
🇧🇪Leuven, Belgium
Sygehus Soenderjylland, Sønderborg
🇩🇰Sønderborg, Denmark
Klinikum Klagenfurt
🇦🇹Klagenfurt, Austria
Ospedale Civile di Ivrea
🇮🇹Ivrea, Piemonte, Italy
Universitätsklinikum Jena
🇩🇪Jena, Germany
Ospedale Centrale di Bolzano
🇮🇹Bolzano, Trentino, Italy
Azienda Ospedaliera dei Colli - Monaldi
🇮🇹Napoli, Italy
Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Girona, Spain