No Specific Conditions Under Study. Primary Focus: Adult Subjects Who Require PICC Placement
Conditions
Keywords
central venous catheters, peripherally inserted central catheters (PICC_, Electrocardiography (ECG), intravascular ECG, Tip Positioning System
Brief summary
Phase I * determine the location of the peripherally inserted central catheter (PICC) tip upon observation of maximum p-wave amplitude Phase II * determine the precision of PICC placement in the Sherlock 3CG group versus the standard PICC placement
Detailed description
The feasibility phase of this study (Phase I) is a prospective, single arm, single-center feasibility study to determine the distance of the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave after PICC tip placement using the Sherlock 3CG system. Subjects judged by site personnel to require PICC placement will be screened against the study inclusion/exclusion criteria. Those subjects meeting the study criteria will be offered enrollment into the study. Informed consent will be obtained prior to subject enrollment. PICC nurses who have been fully trained in the correct use of the Sherlock 3CG Tip Positioning System will perform the PICC placement procedures in the fluoroscopy suite. Serious adverse events (SAEs) will be collected, but collection of non-serious AEs will be limited to those adverse events (AEs) considered to be study procedure and/or device-related. Subject follow up will be complete 30 days following the date of the study PICC procedure. The results of the feasibility phase will be used to determine: 1. the distance, if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in the pivotal phase of the study (See Section 3.5.3), in order to have the PICC tip at the upper cavoatrial junction. 2. the movement of the cardiovascular anatomy, if any, when the arm is adducted from above the head to the side of the subject. 3. the movement of the PICC tip when the arm is moved from the 90° angle to the side. Phase II (Pivotal) will not begin until the Phase I (feasibility) is complete. The Phase II study is a prospective, single-center, controlled, blinded, randomized study to compare the Sherlock 3CG as a tool in guiding PICC placement to the standard blind technique (control). Subjects judged by site personnel to require PICC placement will be screened against the study inclusion/exclusion criteria. Those subjects meeting the study criteria will be offered participation into the study. Informed consent will be obtained prior to subject enrollment. Subjects will be randomly assigned to either the Sherlock 3CG group or the control group in a 1:1 fashion. Due to the different placement techniques being utilized, the PICC nurses and study coordinator will not be blinded to the study device. PICC nurses who have been fully trained in the correct use of the Sherlock 3CG will perform the PICC placement procedures in the fluoroscopy suite. Serious adverse events (SAEs) will be collected, but collection of non-serious AEs will be limited to those AEs considered to be study procedure and/or device-related. Subject follow up will be complete 30 days following the date of the study PICC procedure. Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination. Phase II was cancelled.
Interventions
DEVICESherlock 3CG
Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
OTHERBlind Placement
PICCs will be placed blindly, without the use of any tip location/positioning device.
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, age ≥ 21years 2. Require 5 F dual lumen or 4 F single lumen PowerPICC or PowerPICC SOLO placement as part of standard care 3. Be able to undergo study procedures 4. Subject is able to comply with all study requirements and be available for 30 day follow-up visit. 5. Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative
Exclusion criteria
1. Subject has a contraindication to PICC placement as listed in the Instructions for Use (IFU) (See Section 18.2) 2. Subject has been previously randomized for this study. 3. Subject is unable to lie in the supine position on the fluoroscopy table 4. Subject had radiation therapy within the last three years 5. Subject has an existing pregnancy 6. Subject has known glomerular filtration rate (GFR) \<45 ml/min/1.73m2 7. Subject has a functioning pacemaker or defibrillator 8. Subject has an artificial heart or heart transplant 9. Subject has anatomical abnormalities of the central venous system 10. Subject has atrial fibrillation or other atrial arrhythmias in which a p-wave was not consistently present on ECG 11. Subject has internal wires that may interfere with imaging 12. Subject has an existing central venous catheter 13. Subject is unable to raise arms above the head while lying down. 14. Subject has a BMI ≥45 15. The clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment. 16. Subject has a known allergy or hypersensitivity to contrast media.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG. | Time of PICC placement (Day 0) | Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary. | Day 0 | Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study. |
| Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement | Day 0 | Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed. Note - this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study. |
| Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject's Side. | Day 0 | Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°). All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study. |
| Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side. | Day 0 | Mean distance (mm) of PICC tip movement when the subject's arm is adducted from a 90° position to the subject's side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side . All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sherlock 3CG Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Device Malfunction | 1 |
| Overall Study | Inability to achieve maximum p-wave | 1 |
| Overall Study | No Contrast Injection | 6 |
Baseline characteristics
| Characteristic | Sherlock 3CG |
|---|---|
| Access Side Left | 6 participants |
| Access Side Right | 12 participants |
| Access Vein Basilic | 9 participants |
| Access Vein Brachial | 9 participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 13.2 |
| Gender Female | 6 Participants |
| Gender Male | 12 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 17 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Reason For PICC Placement Antibiotics | 17 participants |
| Reason For PICC Placement Total Parenteral Nutrition (TPN) | 1 participants |
| Region of Enrollment United States | 18 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.
Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Time frame: Time of PICC placement (Day 0)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sherlock 3CG | Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG. | PICC tip above upper CAJ | 18.8 mm | Standard Deviation 18.1 |
| Sherlock 3CG | Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG. | PICC tip below upper CAJ | 14.3 mm | Standard Deviation 10 |
Secondary
Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement
Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed. Note - this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location. All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sherlock 3CG | Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement | 18 participants |
Secondary
Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side.
Mean distance (mm) of PICC tip movement when the subject's arm is adducted from a 90° position to the subject's side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side . All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Time frame: Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sherlock 3CG | Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side. | PICC tip moved caudally | 22.3 mm | Standard Deviation 12 |
| Sherlock 3CG | Phase I: Amount of PICC Tip Movement When the Subject's Arm is Adducted From a 90° Position to the Subject's Side. | PICC tip moved cephalad | 8.7 mm | Standard Deviation 7 |
Secondary
Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject's Side.
Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°). All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sherlock 3CG | Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject's Side. | 0 mm | Standard Deviation 0 |
Secondary
Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.
Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sherlock 3CG | Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary. | 13.8 mm | Standard Deviation 2 |