Indication for PICC Placement
Conditions
Keywords
PICC, central catheter, vascular access
Brief summary
The purpose of the study is to evaluate differences in the time and costs between Sherlock 3CG® TCS and Chest X-ray to confirm the location of a Peripherally Inserted Central Catheter (PICC).
Detailed description
The study is a cross-sectional, observational design, characterized as a time and motion study. The study will observe subjects and specific outcomes from the time a PICC insertion procedure begins until the subject is cleared for administration of their prescribed therapy. It will compare two approaches for PICC line placement and confirmation of PICC tip placement. The two methods for placing and confirming PICC lines to be examined in this study are: 1) Standard of Care, defined as PICC line placement with Chest X-ray tip confirmation, and 2) Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation. These two approaches are currently in use, and are not investigational. The study will evaluate the time elapsed from the beginning of PICC line placement procedure through the catheter tip confirmation (subject released for IV therapy). A researcher will observe from the time the catheter kit is opened until your catheter is cleared for administration of treatment. Limited subject follow-up includes review of subject medical records related to the PICC line placement. Subjects will be followed only up to the point at which the PICC line tip has been confirmed and the subject has been released to receive IV therapy. For most subjects, all study data will be collected on Day 1. The study is expected to include 120 subjects, 60 subjects will have confirmed PICC line placement using Chest X-ray, and 60 will have confirmed PICC line placement using Sherlock 3CG® TCS. Each group of subjects will be from two clinical sites using either tip confirmation method, for a total of 4 study sites.
Interventions
DEVICEChest X-ray
A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
DEVICESherlock 3CG® TCS
The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)
Sponsors
KJT Group, Inc.
C. R. Bard
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indicated for a PICC based on institutional practices. * Able to read and comprehend English and has signed the Informed Consent Form to participate in the study. * PICC line is placed while a study observer is available and on the study site at the time of the placement.
Exclusion criteria
* Infection, bacteremia, or septicemia is known or suspected. * Body size is insufficient to accommodate the size of the implanted device. * Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, polytetrafluorine (PTFE), and nickle titanium. * Past irradiation of prospective insertion site. * Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site. * Local tissue factors will prevent proper device stabilization and/or access. * Under the age of 22. * Receiving the PICC as a replacement with an over-the-wire exchange. * Pregnant or lactating. * Anatomical irregularities (structural and vascular of the central venous system) which may compromise catheter insertion in both the primary arm and contralateral arm. * Previously enrolled in this clinical study or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation. * Artificial heart or heart transplant. * Anatomical abnormalities of the central venous system. * Atrial fibrillation or other atrial arrhythmia's in which a P wave was not consistently present on ECG. * Clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). | Usually ranges from 0 to 300 minutes from initiation of procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Care Professional (HCP) Procedural Satisfaction (Overall) | Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation). | HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning not at all satisfied and 10 meaning extremely satisfied. |
| Number of Medication Doses Missed Due to PICC Not Being Ready for Use | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | — |
| Number of Lab Draws Missed Due to PICC Not Being Ready for Use | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | — |
| Number of Overtime Hours Worked Per PICC Placement Procedure | Measured from initiation to completion of procedure (usually from 0 to 5 hours) | — |
| Total Number of Chest X-rays Performed Per Subject | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | — |
| Number of Participants With Malpositions | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | — |
| Number of Subsequent Malposition Attempts | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt. |
| Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy) | Usually ranges from 0 to 300 minutes | Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-interventional radiology (IR) labor cost per PICC insertion, IR labor cost per PICC insertion). |
| Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event) | Usually ranges from 0 to 30 minutes | Nurse time associated with a malposition was defined as the time between when the nurse opened gathered materials for correcting the malposition (e.g., PICC kit, dressing change kit, saline, syringe) and when the subject was released for IV therapy. |
| Nurse Time Associated With Initial PICC Placement (Per Patient) | Usually ranges from 0 to 150 minutes | Nurse time associated with initial PICC placement was defined as the time between when the nurse arrived at the subject and when the nurse left the room, minus the amount of time it took to conduct the research consent with the subject for the study; it includes time spent gathering supplies (before entering the subject's room) and any consents obtained for the PICC procedure (not study-related consents). |
Countries
United States
Participant flow
Recruitment details
Site healthcare providers identified potential subjects referred for placement of a PICC as part of their routine care. Subjects met all eligibility criteria listed in the study protocol. Recruitment occurred between May 2015 and May 2016.
Pre-assignment details
Three patients in the Standard of Care (Chest X-ray) arm and five patients in the Sherlock 3CG TCS arm were excluded from the study as screen failures following enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (Chest X-ray) Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).
X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition) | 60 |
| Sherlock 3CG® TCS Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.
Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition) | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen failure | 3 | 5 |
Baseline characteristics
| Characteristic | Standard of Care (Chest X-ray) | Sherlock 3CG® TCS | Total |
|---|---|---|---|
| Age, Continuous | 56.22 years | 61.75 years | 58.985 years |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 22 Participants | 29 Participants | 51 Participants |
| Sex: Female, Male Male | 38 Participants | 31 Participants | 69 Participants |
| Urgency of PICC Order Greater urgency than normal | 23 Participants | 6 Participants | 29 Participants |
| Urgency of PICC Order Not urgent | 37 Participants | 54 Participants | 91 Participants |
| Urgency of PICC Order Very urgent (STAT) | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).
Time frame: Usually ranges from 0 to 300 minutes from initiation of procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). | 176.32 minutes | Standard Deviation 249.84 |
| Sherlock 3CG® TCS | Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). | 33.93 minutes | Standard Deviation 25.63 |
Secondary
Health Care Professional (HCP) Procedural Satisfaction (Overall)
HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning not at all satisfied and 10 meaning extremely satisfied.
Time frame: Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Health Care Professional (HCP) Procedural Satisfaction (Overall) | 6.22 units on a scale | Standard Deviation 2.9 |
| Sherlock 3CG® TCS | Health Care Professional (HCP) Procedural Satisfaction (Overall) | 9.22 units on a scale | Standard Deviation 1.55 |
Secondary
Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (Chest X-ray) | Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use | 0 Venous Access Devices (VADs) |
| Sherlock 3CG® TCS | Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use | 0 Venous Access Devices (VADs) |
Secondary
Number of Lab Draws Missed Due to PICC Not Being Ready for Use
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Number of Lab Draws Missed Due to PICC Not Being Ready for Use | 0.07 Lab draws | Standard Deviation 0.25 |
| Sherlock 3CG® TCS | Number of Lab Draws Missed Due to PICC Not Being Ready for Use | 0 Lab draws | Standard Deviation 0 |
Secondary
Number of Medication Doses Missed Due to PICC Not Being Ready for Use
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Number of Medication Doses Missed Due to PICC Not Being Ready for Use | 0.07 Doses | Standard Deviation 0.31 |
| Sherlock 3CG® TCS | Number of Medication Doses Missed Due to PICC Not Being Ready for Use | 0 Doses | Standard Deviation 0 |
Secondary
Number of Overtime Hours Worked Per PICC Placement Procedure
Time frame: Measured from initiation to completion of procedure (usually from 0 to 5 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Number of Overtime Hours Worked Per PICC Placement Procedure | 0.07 hours | Standard Deviation 0.25 |
| Sherlock 3CG® TCS | Number of Overtime Hours Worked Per PICC Placement Procedure | 0 hours | Standard Deviation 0 |
Secondary
Number of Participants With Malpositions
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care (Chest X-ray) | Number of Participants With Malpositions | 12 Participants |
| Sherlock 3CG® TCS | Number of Participants With Malpositions | 0 Participants |
Secondary
Number of Subsequent Malposition Attempts
This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt.
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (Chest X-ray) | Number of Subsequent Malposition Attempts | 12 malposition adjustment attempts |
| Sherlock 3CG® TCS | Number of Subsequent Malposition Attempts | 0 malposition adjustment attempts |
Secondary
Total Number of Chest X-rays Performed Per Subject
Time frame: Measured from initiation to completion of procedure (usually from 0 to 300 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care (Chest X-ray) | Total Number of Chest X-rays Performed Per Subject | 1.25 Chest X-rays |
| Sherlock 3CG® TCS | Total Number of Chest X-rays Performed Per Subject | 0.03 Chest X-rays |
Other Pre-specified
Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy)
Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-interventional radiology (IR) labor cost per PICC insertion, IR labor cost per PICC insertion).
Time frame: Usually ranges from 0 to 300 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy) | 367 US dollars | Standard Deviation 324.21 |
| Sherlock 3CG® TCS | Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy) | 272 US dollars | Standard Deviation 67.03 |
Other Pre-specified
Nurse Time Associated With Initial PICC Placement (Per Patient)
Nurse time associated with initial PICC placement was defined as the time between when the nurse arrived at the subject and when the nurse left the room, minus the amount of time it took to conduct the research consent with the subject for the study; it includes time spent gathering supplies (before entering the subject's room) and any consents obtained for the PICC procedure (not study-related consents).
Time frame: Usually ranges from 0 to 150 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Nurse Time Associated With Initial PICC Placement (Per Patient) | 42.50 minutes | Standard Deviation 16.81 |
| Sherlock 3CG® TCS | Nurse Time Associated With Initial PICC Placement (Per Patient) | 42 minutes | Standard Deviation 16.35 |
Other Pre-specified
Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)
Nurse time associated with a malposition was defined as the time between when the nurse opened gathered materials for correcting the malposition (e.g., PICC kit, dressing change kit, saline, syringe) and when the subject was released for IV therapy.
Time frame: Usually ranges from 0 to 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event) | 11.67 minutes | Standard Deviation 10.5 |