Time and resources of peripherally inserted central catheter insertion procedures: a comparison between blind insertion/chest X-ray and a real time tip navigation and confirmation system

Figures & data

Table 1 Subject inclusion and exclusion criteria

Inclusion criteria

1. Indicated for a PICC based on institutional practices.

2. Able to read and comprehend English and has signed the ICF to participate in the study.

3. PICC line is placed while a study observer is available and on the study site at the time of placement.

Exclusion criteria

1. Infection, bacteremia, or septicemia is known or suspected.

2. Body size is insufficient to accommodate the size of the implanted device.

3. Known or is suspected to be allergic to materials contained in the device. Materials in the device include polyurethane, stainless steel, polyimide, silicone, PTFE, and nickel titanium.

4. Past irradiation of prospective insertion site.

5. Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.

6. Local tissue factors will prevent proper device stabilization and/or access.

7. Under the age of 22 years.

8. Receiving the PICC as a replacement with an over-the-wire exchange.

9. Pregnant or lactating.

10. Anatomical irregularities (structural and vascular of the central venous system) that may compromise catheter insertion in both the primary arm and the contralateral arm.

11. Previously enrolled in this clinical study or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation.

12. Artificial heart or heart transplant.

13. Anatomical abnormalities of the central venous system.

14. Atrial fibrillation or other atrial arrhythmias in which a P-wave was not consistently present on ECG.

15. Clinician is unable to obtain accurate external measurement due to anatomical abnormalities or personal/medical equipment.

Abbreviations: PICC, peripherally inserted central catheter; ICF, informed consent form; PTFE, polytetraflourine; ECG, electrocardiogram.

Table 2 Study end points

Primary end point

1. Time from initiation of procedure (opening of PICC kit) to release for IV therapy.

Secondary end points

1. Total number of CXRs performed per subject.

2. Number of malpositions.

3. Procedures and materials needed to correct malpositions.

4. HCP procedural satisfaction.

5. Number of additional VADs required due to PICC not being ready for use.

6. Number of missed doses due to PICC not being ready for use.

7. Number of missed laboratory draws due to PICC not being ready for use.

8. Number of overtime hours worked per placement.

Abbreviations: PICC, peripherally inserted central catheter; IV, intravenous; CXRs, chest X-rays; HCP, health care professional; VADs, vascular access devices.

Table 3 Statistical analyses

End points	Statistical analysis	Pre-specified
Time elapsed from the beginning of the PICC insertion procedure to catheter tip confirmation (subject released for IV therapy)	Wilcoxon rank sum test	Yes
Number of CXRs	Wilcoxon rank sum test	Yes
Number of subjects with malpositions during the initial PICC insertion	Two-sample test of proportions	Yes
Overall procedural satisfaction	Wilcoxon rank sum test	No
Number of total missed medication doses per subject	Wilcoxon rank sum test	No
Number of total missed laboratory draws per subject	Two-sample t-test assuming unequal variances	No
Number of overtime hours worked per subject	Two-sample t-test assuming unequal variances	No
Procedural costs	Wilcoxon rank sum test	No

Abbreviations: PICC, peripherally inserted central catheter; IV, intravenous; CXRs, chest X-rays.

Figure 1 Analytic framework.

Notes: *Unit costs that were not derived from the Time and Motion study. ^#Data from the Time and Motion study that were utilized for clinical projections only (ie, not included in the cost analysis).
Abbreviations: PICC, peripherally inserted central catheter; TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; IR, Interventional Radiology.

Table 4 Procedural time and nurse time (minutes)

Time measurement	Study arm						p-Value
	Sherlock 3CG™ TCS			BI/CXR
	Mean	SD	n	Mean	SD	n
Time from initiation of procedure to release for IV therapy	33.93	25.63	60	176.32	249.84	60	0.001
Time associated with initial PICC placement	33.93	25.63	60	29.05	7.84	60	n/a
Time associated with confirming tip after initial placement	0	0	0	78.04	51.67	60	n/a
Time associated with additional procedures to confirm tip	0	0	0	69.23	250.01	60	n/a
PICC nurse time associated with initial PICC insertion	42.00	16.35	60	42.50	16.81	60	n/a
PICC nurse time associated with malposition adjustment after initial insertion	0	0	0	11.67	7.97	7	n/a
Subject time in IR	0	0	0	100.40	107.06	6	n/a

Note: Only “Time from initiation of procedure to release for IV therapy” was tested statistically.

Abbreviations: TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; SD, standard deviation; IV, intravenous; PICC, peripherally inserted central catheter; n/a, not applicable; IR, Interventional Radiology.

Table 5 CXRs performed

Attribute	Study arm		p-Value
	Sherlock 3CG™ TCS (n=60)	BI/CXR (n=60)
Number of subjects receiving a confirmatory CXR for initial PICC placement	2 (3%)	60 (100%)	n/a
Number of subjects receiving a second CXR after first malposition adjustment	0 (0%)	13 (22%)	n/a
Number of subjects receiving a third CXR after second malposition adjustment	0 (0%)	2 (3%)	n/a
Number of subjects who did not receive a CXR	58 (97%)	0 (0%)	n/a
Total number of CXRs	2	75	n/a
Mean number of total CXRs performed per subject (SD)	0.03 (0.18)	1.25 (0.51)	<0.001

Note: Only “Mean number of total CXRs performed per subject (SD)” was tested statistically.

Abbreviations: CXRs, chest X-rays; TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; PICC, peripherally inserted central catheter; n/a, not applicable; SD, standard deviation.

Table 6 Number of subjects with malposition

Attribute	Study arm		p-Value
	Sherlock 3CG™ TCS (n=60)	BI/CXR (n=60)
Number of subjects with malposition during initial PICC insertion	0 (0%)	12 (20%)	<0.001
Number of subjects with remaining malposition during first malposition adjustment	0 (0%)	2 (3%)	n/a
Number of subjects with no malposition	60 (100%)	48 (80%)	n/a

Note: Only “Number of subjects with malposition during initial PICC insertion” was tested statistically.

Abbreviations: TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; PICC, peripherally inserted central catheter; n/a, not applicable.

Table 7 Other secondary end points

Attribute	Study arm		p-Value
	Sherlock 3CG™ TCS (n=60)	BI/CXR (n=60)
Satisfaction with procedure (overall)	9.22 (1.55)	6.22 (2.90)	<0.001
Mean number of additional venous access devices required per subject	0 (0)	0 (0)	n/a
Mean number of missed medication doses per subject	0 (0)	0.07 (0.31)	0.0807
Mean number of missed laboratory draws per subject	0 (0)	0.07 (0.25)	0.0445
Mean number of overtime hours per subject	0 (0)	0.07 (0.25)	0.0445
Mean total procedural cost (materials, labor, X-ray)	$273 ($67.03)	$367 ($324.21)	<0.001

Notes: Mean (SD) shown. “Mean number of additional venous access devices required per subject” not tested statistically. All costs are reported in USD. Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-IR labor cost per PICC insertion, IR labor cost per PICC insertion).

Abbreviations: TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; n/a, not applicable; SD, standard deviation; PICC, peripherally inserted central catheter; IR, Interventional Radiology.

Table 8 Resource data inputs utilized in the modeled analysis

Resource inputs	Study arm
	Sherlock 3CG™ TCS (n=60)	BI/CXR (n=60)
Initial CXR (% patients)	7%a	100% (60/60)
Additional CXR after malposition (% patients)	0% (0/60)	23% (14/60)
Additional CXR but no adjustment (% patients)b	3% (2/60)	2% (1/60)
Procedures to correct malposition (% malpositions)
Bedside PICC team to correct malposition	–	50% (7/14)
IR to correct malposition	–	43% (6/14)
No adjustment/procedure required to correct malposition	–	7% (1/14)
Bedside staff time for malposition adjustment (minutes)	–	11.67

Notes: Resource inputs are derived from the Time and Motion study unless otherwise specified.

a Given a range of patients that may be ineligible for ECG-based tip confirmation (2.8%³⁰ to 7%¹¹), it was conservatively assumed that 100% would attempt the Sherlock 3CG TCS and only 93% would be eligible. Patients may be ineligible for Sherlock 3CG TCS based on the reported proportion of patients who meet the exclusion criteria, such as patients with a non-discernible P-wave (eg, patients with atrial fibrillation, atrial flutter, severe tachycardia, or pacemaker-driven rhythm).

b Two subjects (3%) in the Sherlock 3CG TCS arm received a CXR after the initial PICC placement. These subjects had implantable devices near the PICC line. The hospital’s protocol required a CXR before the subjects could be released for IV therapy to confirm there was no disruption to the implantable device due to the PICC line. One subject (2%) in the BI/CXR arm received a second CXR after the initial PICC placement despite not having a malposition. A second CXR was ordered to better visualize the PICC tip location.

Abbreviations: TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; CXR, chest X-ray; PICC, peripherally inserted central catheter; IR, Interventional Radiology; ECG, electrocardiogram; IV, intravenous.

Table 9 Cost inputs utilized in the modeled analysis

Cost inputs	USD
Average upcharge cost per PICC for Sherlock 3CG™ TCS vs. BI/CXR	$87
Capital equipment cost
BI/CXR	$14,000a
Sherlock 3CG TCS	$18,300a
CXR cost	$60.80b
Material costs to correct malposition at bedside	$31.32
Bedside staff hourly wage	$34.30
Cost of procedures requiring IR to correct malpositions	$862.50c

Notes: Cost inputs are derived from the Time and Motion study unless otherwise specified.

a Capital costs for BI/CXR were based on an approximate cost of $14,000 for ultrasound, and capital costs for Sherlock 3CG TCS were based on $14,000 for Bard Site~Rite 6™ ultrasound plus an approximate $4,300 upcharge for the Sherlock 3CG TCS capital equipment upgrade. The capital equipment life cycle was assumed to be 5 years, and therefore, only one unit would be required within the 3-year time horizon of the cost analysis.³¹

b The cost of a CXR was based on the 2016 national average payment rate for a CXR (1 frontal view, CPT 71010).³²

c The cost of procedures requiring IR to correct malpositions was based on the 2016 national average payment rate for repositioning of venous catheter (CPT 36597).³²

Abbreviations: TCS, Tip Confirmation System; BI/CXR, blind insertion with confirmatory chest X-ray; CXR, chest X-ray; IR, Interventional Radiology.

Figure 2 Cumulative change in total cost by year (in USD).

Table 10 Total cost per year based on 1,000 annual PICC placements

Year of analysis	Total cost with BI/CXR	Total cost with Sherlock 3CG™ TCS	Incremental difference	Interpretation
Year 1	$320,682	$251,583	−$69,100	Cost savings
Year 2	$306,682	$233,283	−$73,400	Cost savings
Year 3	$306,682	$233,283	−$73,400	Cost savings

Abbreviations: PICC, peripherally inserted central catheter; BI/CXR, blind insertion with confirmatory chest X-ray; TCS, Tip Confirmation System.

Figure 3 One-way sensitivity analysis on the 3-year cumulative change in cost.

Abbreviations: BI/CXR, blind insertion with confirmatory chest X-ray; PICC, peripherally inserted central catheter; TCS, Tip Confirmation System; IR, Interventional Radiology.

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