Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KJT Group, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (Chest X-ray) | Other | Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray). |
|
| Sherlock 3CG® TCS | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest X-ray | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth J Tomaszewski, PhD | KJT Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Maitland | Florida | 32751 | United States | ||
| University of Maryland - Baltimore |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Sherlock 3CG® TCS | Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® Tip Confirmation System (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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy). | Posted | Mean | Standard Deviation | minutes | Usually ranges from 0 to 300 minutes from initiation of procedure |
|
Subjects were followed only up to the point at which the PICC line tip was confirmed and they were released to receive therapy (usually from 0 to 300 minutes following procedure initiation). Once they were released to receive therapy, and review of electronic medical record (EMR) data was complete, there was no other subject follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Gilbert, BSN, RN | Bard Access Systems, Inc. | 407-489-0835 | Gina.Gilbert@crbard.com |
Not provided
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002404 | Catheterization |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sherlock 3CG® TCS | Device | 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) | Procedure | 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) |
|
| 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. | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
| 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". | Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation). |
| 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) |
| 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) |
| Usually ranges from 0 to 150 minutes |
| 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. | Usually ranges from 0 to 30 minutes |
| 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). | Usually ranges from 0 to 300 minutes |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Peninsula Regional Medical Center | Salisbury | Maryland | 21801 | United States |
| Unity Hospital | Rochester | New York | 14626 | United States |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Urgency of PICC Order | Count of Participants | Participants |
|
| 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) |
|
|
| Secondary | Total Number of Chest X-rays Performed Per Subject | Posted | Mean | Full Range | Chest X-rays | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
|
|
|
| Secondary | Number of Participants With Malpositions | Posted | Count of Participants | Participants | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
|
|
|
| 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. | Posted | Number | malposition adjustment attempts | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
|
|
|
| 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". | Posted | Mean | Standard Deviation | units on a scale | Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation). |
|
|
|
| Secondary | Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use | Posted | Number | Venous Access Devices (VADs) | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
|
|
|
| Secondary | Number of Medication Doses Missed Due to PICC Not Being Ready for Use | Posted | Mean | Standard Deviation | Doses | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
|
|
|
| Secondary | Number of Lab Draws Missed Due to PICC Not Being Ready for Use | Posted | Mean | Standard Deviation | Lab draws | Measured from initiation to completion of procedure (usually from 0 to 300 minutes) |
|
|
|
| Secondary | Number of Overtime Hours Worked Per PICC Placement Procedure | Posted | Mean | Standard Deviation | hours | Measured from initiation to completion of procedure (usually from 0 to 5 hours) |
|
|
|
| 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). | Posted | Mean | Standard Deviation | minutes | Usually ranges from 0 to 150 minutes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | Usually ranges from 0 to 30 minutes | events | events |
|
|
|
| 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). | Posted | Mean | Standard Deviation | US dollars | Usually ranges from 0 to 300 minutes |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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) | 0 | 60 | 0 | 60 |
Not provided
Not provided
| D057510 |
| Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |