Peripherally Inserted Central Catheter
Conditions
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.
Interventions
insertion of a Peripherally Inserted Central Catheter (PICC)
Sponsors
FGK Clinical Research GmbH
Becton, Dickinson and Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | from insertion though removal or 180 days, whichever comes first | Incidence of any new occurrence of local infection |
| 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 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 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 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: 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 |
| 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used | during the insertion procedure | The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used |
Countries
Austria, Belgium, Czechia, Denmark, Germany, Italy, Netherlands, Spain, Switzerland
Participant flow
Recruitment details
The study was conducted at 14 centers in 9 European countries. The first participant was enrolled on June 18, 2020 and the last participant had the last study visit on January 05, 2022. The choice of the specific device type, size, number of lumens, and length required for an individual patient was left to the discretion of the clinician.
Pre-assignment details
In this post market study, 450 patients, who were to receive a PICC from the PowerPICC family as per routine clinical practice, were observed for up to 180 days after device's insertion or until removal of the device because the therapy was completed, changed or cancelled. Patients, who died during the study and had the device in place at the time of death, were considered as having completed the therapy.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Patients who received a device from the BD PowerPICC family according to the clinical practice. | 450 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 53 |
| Overall Study | Death | 29 |
| Overall Study | Device deficiency | 19 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | other reasons | 11 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 14.8 |
| Body Mass Index (BMI) | 26.30 kg/m² STANDARD_DEVIATION 5.27 |
| Catheter insertion - Catheter length trimmed Catheter length not trimmed | 150 Participants |
| Catheter insertion - Catheter length trimmed Catheter length trimmed | 300 Participants |
| Catheter insertion - Catheter tip repositioning Catheter tip not repositioned | 19 Participants |
| Catheter insertion - Catheter tip repositioning Catheter tip repositioned | 430 Participants |
| Catheter insertion - Catheter tip repositioning Missing information - no study device placed | 1 Participants |
| Catheter insertion - Device placement successful Device placement successful | 448 Participants |
| Catheter insertion - Device placement successful Device placement unsuccessful | 2 Participants |
| Catheter insertion - Dressing type Gauze | 10 Participants |
| Catheter insertion - Dressing type Missing information - no study device placed | 1 Participants |
| Catheter insertion - Dressing type Other | 29 Participants |
| Catheter insertion - Dressing type Transparent semi-permeable membrane | 410 Participants |
| Catheter insertion - Local anesthesia used Local anesthesia not used | 2 Participants |
| Catheter insertion - Local anesthesia used Local anesthesia used | 448 Participants |
| Catheter insertion - Location of procedure performance Bedside | 190 Participants |
| Catheter insertion - Location of procedure performance Interventional radiology | 108 Participants |
| Catheter insertion - Location of procedure performance Other | 152 Participants |
| Catheter insertion - Method to confirm catheter tip positioning Other | 91 Participants |
| Catheter insertion - Method to confirm catheter tip positioning Sherlock 3CG | 202 Participants |
| Catheter insertion - Method to confirm catheter tip positioning X-ray | 157 Participants |
| Catheter insertion - Number of insertion attempts Number of insertion attempts=1 | 408 Participants |
| Catheter insertion - Number of insertion attempts Number of insertion attempts=2 | 32 Participants |
| Catheter insertion - Number of insertion attempts Number of insertion attempts=3 | 8 Participants |
| Catheter insertion - Number of insertion attempts Number of insertion attempts=4 | 1 Participants |
| Catheter insertion - Number of insertion attempts Number of insertion attempts=5 | 1 Participants |
| Catheter insertion - PICC insertion as per Instructions For Use (IFUs) Missing information - no study device placed | 1 Participants |
| Catheter insertion - PICC insertion as per Instructions For Use (IFUs) PICC inserted as per the IFUs | 449 Participants |
| Catheter insertion - Placement of catheter Left arm | 193 Participants |
| Catheter insertion - Placement of catheter Right arm | 257 Participants |
| Catheter insertion - presence of a second implanted line vascular access device No presence of a second implanted line vascular access device | 360 Participants |
| Catheter insertion - presence of a second implanted line vascular access device Presence of a second implanted line vascular access device | 90 Participants |
| Catheter insertion - Sherlock 3CG used Sherlock 3CG not used | 191 Participants |
| Catheter insertion - Sherlock 3CG used Sherlock 3CG used | 259 Participants |
| Catheter insertion - Sherlock TLS used Sherlock TLS not used | 450 Participants |
| Catheter insertion - Sherlock TLS used Sherlock TLS used | 0 Participants |
| Catheter insertion - Stabilization method Missing information - no study device placed | 1 Participants |
| Catheter insertion - Stabilization method SecurAcath | 59 Participants |
| Catheter insertion - Stabilization method StatLock | 390 Participants |
| Catheter insertion - Tunneling used Tunneling not used | 424 Participants |
| Catheter insertion - Tunneling used Tunneling used | 26 Participants |
| Catheter insertion - Vein accessed Basilic | 253 Participants |
| Catheter insertion - Vein accessed Brachial | 180 Participants |
| Catheter insertion - Vein accessed Cephalic | 15 Participants |
| Catheter insertion - Vein accessed Other | 2 Participants |
| Catheter insertion - Vessel/catheter ratio done prior to insertion Vessel/catheter ratio done prior to insertion | 272 Participants |
| Catheter insertion - Vessel/catheter ratio done prior to insertion Vessel/catheter ratio not done prior to insertion | 178 Participants |
| Intended access duration Long-term (>=30 days) | 353 Participants |
| Intended access duration Short-term (<30 days) | 97 Participants |
| Primary diagnosis for current admission Cardiac | 12 Participants |
| Primary diagnosis for current admission Gastrointestinal | 18 Participants |
| Primary diagnosis for current admission Infection | 42 Participants |
| Primary diagnosis for current admission Neurological | 8 Participants |
| Primary diagnosis for current admission Oncological | 328 Participants |
| Primary diagnosis for current admission Other | 7 Participants |
| Primary diagnosis for current admission Surgical | 29 Participants |
| Primary diagnosis for current admission Trauma | 2 Participants |
| Primary diagnosis for current admission Vascular | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 439 Participants |
| Reason for PICC placement Central venous pressure monitoring | 2 participants |
| Reason for PICC placement Hydration support | 20 participants |
| Reason for PICC placement Intravenous therapy:antimicrobial/antifungal | 79 participants |
| Reason for PICC placement Intravenous therapy:blood product and transfusion | 21 participants |
| Reason for PICC placement Intravenous therapy: chemotherapy | 313 participants |
| Reason for PICC placement Intravenous therapy: immunoglobulins | 2 participants |
| Reason for PICC placement Intravenous therapy:pain management | 30 participants |
| Reason for PICC placement Intravenous therapy: total parenteral nutrition | 50 participants |
| Reason for PICC placement Intravenous therapy: vasopressors | 4 participants |
| Reason for PICC placement Limited peripheral access | 125 participants |
| Reason for PICC placement Nutritional support | 15 participants |
| Reason for PICC placement Other includes post covid pancreatytis therapy and hypertension IV pharmacotherapy | 3 participants |
| Reason for PICC placement Serial blood sampling | 61 participants |
| Reason for PICC placement Serial radiographic studies | 3 participants |
| Reason for PICC placement Thrombocytopenia or coagulopathy | 3 participants |
| Region of Enrollment Austria | 16 participants |
| Region of Enrollment Belgium | 10 participants |
| Region of Enrollment Czechia | 59 participants |
| Region of Enrollment Denmark | 59 participants |
| Region of Enrollment Germany | 21 participants |
| Region of Enrollment Italy | 212 participants |
| Region of Enrollment Netherlands | 40 participants |
| Region of Enrollment Spain | 6 participants |
| Region of Enrollment Switzerland | 27 participants |
| Relevant medical history Abnormalities of the arms | 7 Participants |
| Relevant medical history Abnormalities of the chest wall | 5 Participants |
| Relevant medical history Central venous access devices | 93 Participants |
| Relevant medical history Current treatment with anticoagulants | 27 Participants |
| Relevant medical history History of catheter related bloodstream inf. | 4 Participants |
| Relevant medical history History of coagulopathy | 9 Participants |
| Relevant medical history History of deep vein thrombosis | 10 Participants |
| Relevant medical history History of hypercoagulopathy | 2 Participants |
| Relevant medical history History of LN dissection/ lymphedema | 49 Participants |
| Relevant medical history History of phlebitis | 7 Participants |
| Relevant medical history History of venous thrombosis | 13 Participants |
| Relevant medical history Implantable devices | 11 Participants |
| Relevant medical history Known absence of a p-wave | 6 Participants |
| Relevant medical history Other relevant medical history | 161 Participants |
| Relevant medical history Past and/or current anatomical abnormalities of the central venous system | 6 Participants |
| Relevant medical history Past and/or current atrial fibrillation or other atrial arrhythmias that affects the p-wave | 36 Participants |
| Relevant medical history Renal impairment | 4 Participants |
| Sex: Female, Male Female | 226 Participants |
| Sex: Female, Male Male | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 32 / 450 |
| other Total, other adverse events | 162 / 450 |
| serious Total, serious adverse events | 58 / 450 |
Outcome results
Primary
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
Population: A total of 447 patients received treatment via the study device and were included in the evaluable set, used for the primary performance calculation.~The percentage of PICCs that remains in place through the completion of therapy (success) was calculated by dividing successful cases by the total number of devices with non-missing data on success/failure.Therefore, 2 subjects lost to follow-up were not included in the calculation of percentage.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period. | 81.8 % of subjects after PICC placement |
Primary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | 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. | 1.6 % of subjects after PICC placement |
Secondary
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
Population: A total of 447 subjects received treatment via the study device and were included in the evaluable set, used for the performance calculation. However, 2 subjects were lost to follow-up and were not included in the calculation of percentage.~Patent catheters are defined as functional catheters through therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Performance: Percent of Patent Catheters | 93.9 % of subjects after PICC placement |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Performance: Percent of Placement Success in Single Insertion Attempt | 90.4 % of subjects after PICC placement |
Secondary
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
Population: The analysis is based on the investigators who completed the questionnaire and answer the respective question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Guidewire withdrawal/removal was easy or very easy | 425 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Investigators were agree or strongly agree with Stylet facilitated placement | 338 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Force to advance the stylet acceptable | 352 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Guidewire usage was easy or very easy | 419 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Force to advance the guidewire acceptable | 448 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Force to withdraw/remove the guidewire acceptable | 448 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Guidewire integrity | 448 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Investigators were agree or strongly agree with Guidewire facilitated placement | 425 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Stylet usage was easy or very easy | 335 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Stylet withdrawal/removal was easy or very easy | 343 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Force to withdraw/remove the stylet acceptable | 353 Participants |
| All Subjects | Secondary Performance - Usability: Ease of Insertion | Stylet integrity | 356 Participants |
Secondary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Accidental Dislodgement. | 3.8 % of subjects after PICC placement |
Secondary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Catheter-related Bloodstream Infection. | 1.6 % of subjects after PICC placement |
Secondary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Extravasation | 0 % of subjects after PICC placement |
Secondary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Local Infection | 4.5 % of subjects after PICC placement |
Secondary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection | 3.1 % of subjects after PICC placement |
Secondary
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
Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Phlebitis | 0 % of subjects after PICC placement |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Vessel Laceration. | 0.4 % of subjects after PICC placement |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Secondary Safety: Incidence of Vessel Perforation. | 0.2 % of subjects after PICC placement |
Post Hoc
Post-hoc Analysis: Device Lifetime
Post-hoc analysis: overall mean device lifetime
Time frame: from insertion though removal or 180 days, whichever comes first
Population: The overall mean device lifetime
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Post-hoc Analysis: Device Lifetime | 90.64 days | Standard Deviation 68.41 |
Other Pre-specified
Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used
The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used
Time frame: during the insertion procedure
Population: The analysis is based on the investigators who completed the questionnaire and answer the respective question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used | 244 Participants |